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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02164864
Registration number
NCT02164864
Ethics application status
Date submitted
13/06/2014
Date registered
17/06/2014
Date last updated
31/07/2018
Titles & IDs
Public title
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
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Scientific title
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
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Secondary ID [1]
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0
2013-003201-26
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Secondary ID [2]
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1160.186
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Percutaneous Coronary Intervention
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dabigatran Etexilate 110mg
Treatment: Drugs - Warfarin 3mg
Treatment: Drugs - Aspirin
Treatment: Drugs - Dabigatran Etexilate 150mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 5mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 1mg
Experimental: Dabigatran Etexilate 110mg - Patient to receive Dabigatran Etexilate 110mg twice a day (BID)
Experimental: Dabigatran Etexilate 150mg - Patient to receive Dabigatran Etexilate 150mg twice a day (BID)
Active Comparator: Warfarin - Warfarin doses to maintain INR
Treatment: Drugs: Dabigatran Etexilate 110mg
Active treatment
Treatment: Drugs: Warfarin 3mg
Active comparator
Treatment: Drugs: Aspirin
Active comparator
Treatment: Drugs: Dabigatran Etexilate 150mg
Active treatment
Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator
Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator
Treatment: Drugs: Warfarin 5mg
Active comparator
Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator
Treatment: Drugs: Warfarin 1mg
Active comparator
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Adjudicated ISTH MBE or CRNMBE
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Assessment method [1]
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Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.
Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.
Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.
Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.
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Timepoint [1]
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up to 30 months
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Secondary outcome [1]
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Time to Adjudicated Undetermined Cause of Death
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Assessment method [1]
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Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.
This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.
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Timepoint [1]
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up to 30 months
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Secondary outcome [2]
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Time to Adjudicated Non-CV
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Assessment method [2]
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Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.
Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV
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Timepoint [2]
0
0
up to 30 months
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Secondary outcome [3]
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Time to Adjudicated CV
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Assessment method [3]
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Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.
CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.
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Timepoint [3]
0
0
up to 30 months
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Secondary outcome [4]
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Time to Adjudicated All Cause Death
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Assessment method [4]
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Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.
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Timepoint [4]
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up to 30 months
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Secondary outcome [5]
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Time to First Adjudicated MI
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Assessment method [5]
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Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported
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Timepoint [5]
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up to 30 months
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Secondary outcome [6]
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Time to First Adjudicated Stroke
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Assessment method [6]
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Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction
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Timepoint [6]
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up to 30 months
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Secondary outcome [7]
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Time to First Adjudicated SE
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Assessment method [7]
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Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.
SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.
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Timepoint [7]
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up to 30 months
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Secondary outcome [8]
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Time to First Adjudicated ST
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Assessment method [8]
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Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.
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Timepoint [8]
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up to 30 months
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Secondary outcome [9]
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Time to Composite Endpoint of Death + MI + Stroke
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Assessment method [9]
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Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.
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Timepoint [9]
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up to 30 months
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Secondary outcome [10]
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Time to Composite Endpoint of Death or First Thrombotic Event
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Assessment method [10]
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Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).
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Timepoint [10]
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up to 30 months
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Secondary outcome [11]
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Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
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Assessment method [11]
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Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.
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Timepoint [11]
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0
up to 30 months
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Secondary outcome [12]
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Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
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Assessment method [12]
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Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.
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Timepoint [12]
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up to 30 months
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Male or female patients aged >=18 years
- Patients with Non Valvular Atrial Fibrillation
- Patient presenting with:
An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI
[NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either
Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at
least one lesion eligible for PCI that was successfully treated by elective PCI and
stenting (either BMS or DES)
- The patient must be able to give informed consent in accordance with International
Conference on Harmonisation Good Clinical Practice guidelines and local legislation
and/or regulations.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Patients with a mechanical or biological heart valve prosthesis
- Cardiogenic shock during current hospitalisation
- Stroke within 1 month prior to screening visit
- Patients who have had major surgery within the month prior to screening
- Gastrointestinal haemorrhage within one month prior to screening, unless, in the
opinion of the Investigator, the cause has been permanently eliminated
- Major bleeding episode including life-threatening bleeding episode in one month prior
to screening visit
- Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced
thrombocytopenia (platelet count <100 x 109/L) at screening
- Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by
Cockcroft-Gault equation) <30mL/min at screening
- Active liver disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/06/2017
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Sample size
Target
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Accrual to date
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Final
2725
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Pendlebury Research - Adamstown
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Recruitment hospital [2]
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Gosford Hospital - Gosford
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Wollongong Hospital - Wollongong
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Recruitment hospital [5]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Heartcare Victoria - Bundoora
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Recruitment hospital [8]
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The Geelong Hospital - Geelong
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Recruitment postcode(s) [1]
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2289 - Adamstown
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3083 - Bundoora
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Recruitment postcode(s) [8]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Louisiana
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Maine
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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North Dakota
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Ohio
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Argentina
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Caba
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Argentina
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Quilmes
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Argentina
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San Luis
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Argentina
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San Miguel de Tucumán
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Austria
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Linz
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Austria
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Salzburg
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Wien
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Aalst
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Bonheiden
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Gent
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Gilly
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Middelheim
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Belgium
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Sint-Niklaas
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Belgium
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Tienen
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Ukkel
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Brazil
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Blumenau
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Brazil
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Burgas
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Pleven
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Plovdiv
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Bulgaria
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Sandanski
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Ontario
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Chile
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Santiago
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Chile
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Temuco
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Colombia
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Bogotá
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Cali
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Medellin
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Brno
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Czechia
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Jihlava
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Czechia
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Ostrava
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Praha 4
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Praha
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Czechia
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Slany
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Svitavy
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Czechia
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Usti nad Labem
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Czechia
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Usti nad Orlici
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Denmark
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Århus N
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Finland
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Helsinki
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Finland
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Jyväskylä
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Finland
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Kokkola
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Finland
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Turku
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Boulogne-Billancourt
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France
Query!
State/province [86]
0
0
Brest Cedex 2
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Clermont-Ferrand
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Grenoble
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Marseille
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Montauban
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Montpellier cedex 5
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Nice
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Paris cedex 13
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Paris
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Rouen
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Toulouse
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Bad Friedrichshall
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Bad Nauheim
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Bad Oeynhausen
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Bamberg
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Berlin
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Bielefeld
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Bochum
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Bonn
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Celle
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Coburg
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Dachau
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Dortmund
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Dresden
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Düsseldorf
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Frankfurt
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Fulda
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Göttingen
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Hamburg
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Heidelberg
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Heide
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Homburg/Saar
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Jena
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Kiel
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Langen
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Leipzig
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Ludwigshafen
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Lüdenscheid
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Magdeburg
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Mainz
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Mannheim
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Merseburg
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
München
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Münster
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Paderborn
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Remscheid
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Rostock
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Stuttgart
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Tübingen
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Ulm
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Wesel
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Wuppertal
Query!
Country [138]
0
0
Greece
Query!
State/province [138]
0
0
Alexandroupoli
Query!
Country [139]
0
0
Greece
Query!
State/province [139]
0
0
Athens
Query!
Country [140]
0
0
Greece
Query!
State/province [140]
0
0
Chios
Query!
Country [141]
0
0
Greece
Query!
State/province [141]
0
0
Heraklion, Crete
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Ioannina
Query!
Country [143]
0
0
Greece
Query!
State/province [143]
0
0
Patras
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Thessaloniki
Query!
Country [145]
0
0
Hong Kong
Query!
State/province [145]
0
0
Hong Kong
Query!
Country [146]
0
0
Hungary
Query!
State/province [146]
0
0
Budapest
Query!
Country [147]
0
0
Hungary
Query!
State/province [147]
0
0
Debrecen
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Kecskemet
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Pecs
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Szeged
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Ahmedabad
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Gurgaon
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Hyderabad
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Karamsad
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Nagpur
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Nasik
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
New Delhi
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
Pune
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Seemandhra
Query!
Country [160]
0
0
Ireland
Query!
State/province [160]
0
0
Dublin
Query!
Country [161]
0
0
Ireland
Query!
State/province [161]
0
0
Galway
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Hadera
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Haifa
Query!
Country [164]
0
0
Israel
Query!
State/province [164]
0
0
Holon
Query!
Country [165]
0
0
Israel
Query!
State/province [165]
0
0
Jerusalem
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
Naharia
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Petah Tikva
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Arezzo
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Bergamo
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Brescia
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Catania
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Chieti
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Frosinone
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Grosseto
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Lecce
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Massa
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Napoli
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Roma
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Saronno (VA)
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Seriate
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Torino
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Aichi, Nagoya
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Aomori, Hirosaki
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Chiba, Chiba
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Fukuoka, Kitakyushu
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Fukuoka, Koga
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Fukuoka, Kurume
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Gunma, Maebashi
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Gunma, Takasaki
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Hiroshima, Fukuyama
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Hokkaido, Sapporo
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Hyogo, Himeji
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Hyogo, Kawanishi
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Hyogo, Kobe
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Ishikawa, Kanazawa
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Iwate, Morioka
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Kagawa, Takamatsu
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Kanagawa, Fujisawa
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Kanagawa, Sagamihara
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Kanagawa, Yokohama
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Kyoto, Kyoto
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Miyazaki, Miyazaki
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Osaka, Osaka
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Saitama, Sayama
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Saitama, Wako
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Shiga, Kusatsu
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Shiga, Omihachiman
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Tokushima, Komatsushima
Query!
Country [209]
0
0
Japan
Query!
State/province [209]
0
0
Tokyo, Adachi-ku
Query!
Country [210]
0
0
Japan
Query!
State/province [210]
0
0
Tokyo, Bunkyo-ku
Query!
Country [211]
0
0
Japan
Query!
State/province [211]
0
0
Tokyo, Hachioji
Query!
Country [212]
0
0
Japan
Query!
State/province [212]
0
0
Tokyo, Itabashi-Ku
Query!
Country [213]
0
0
Japan
Query!
State/province [213]
0
0
Tokyo, Shinjuku-ku
Query!
Country [214]
0
0
Korea, Republic of
Query!
State/province [214]
0
0
Busan
Query!
Country [215]
0
0
Korea, Republic of
Query!
State/province [215]
0
0
Daegu
Query!
Country [216]
0
0
Korea, Republic of
Query!
State/province [216]
0
0
Gwangju
Query!
Country [217]
0
0
Korea, Republic of
Query!
State/province [217]
0
0
Pusan
Query!
Country [218]
0
0
Korea, Republic of
Query!
State/province [218]
0
0
Seoul
Query!
Country [219]
0
0
Korea, Republic of
Query!
State/province [219]
0
0
Suncheon
Query!
Country [220]
0
0
Korea, Republic of
Query!
State/province [220]
0
0
Suwon
Query!
Country [221]
0
0
Korea, Republic of
Query!
State/province [221]
0
0
Wonju
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
Aguascalientes
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
Ciudad de Mexico
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
San Luis Potosi
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Zapopan, Jalisco
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Alkmaar
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Eindhoven
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Emmen
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Goes
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Groningen
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Nieuwegein
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Nijmegen
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Uden
Query!
Country [234]
0
0
New Zealand
Query!
State/province [234]
0
0
Hamilton
Query!
Country [235]
0
0
Norway
Query!
State/province [235]
0
0
Arendal
Query!
Country [236]
0
0
Norway
Query!
State/province [236]
0
0
Oslo
Query!
Country [237]
0
0
Norway
Query!
State/province [237]
0
0
Stavanger
Query!
Country [238]
0
0
Norway
Query!
State/province [238]
0
0
Tromsø
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Bialystok
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Bydgoszcz
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Gdansk
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Kielce
Query!
Country [243]
0
0
Poland
Query!
State/province [243]
0
0
Lublin
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Pulawy
Query!
Country [245]
0
0
Poland
Query!
State/province [245]
0
0
Warsaw
Query!
Country [246]
0
0
Poland
Query!
State/province [246]
0
0
Wroclaw
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Zamosc
Query!
Country [248]
0
0
Portugal
Query!
State/province [248]
0
0
Almada
Query!
Country [249]
0
0
Portugal
Query!
State/province [249]
0
0
Coimbra
Query!
Country [250]
0
0
Portugal
Query!
State/province [250]
0
0
Leiria
Query!
Country [251]
0
0
Portugal
Query!
State/province [251]
0
0
Lisboa
Query!
Country [252]
0
0
Portugal
Query!
State/province [252]
0
0
S. Martinho Do Bispo,Coimbra
Query!
Country [253]
0
0
Russian Federation
Query!
State/province [253]
0
0
Barnaul
Query!
Country [254]
0
0
Russian Federation
Query!
State/province [254]
0
0
Chelyabinsk
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Ekaterinburg
Query!
Country [256]
0
0
Russian Federation
Query!
State/province [256]
0
0
Kazan
Query!
Country [257]
0
0
Russian Federation
Query!
State/province [257]
0
0
Kemerovo
Query!
Country [258]
0
0
Russian Federation
Query!
State/province [258]
0
0
Krasnodar
Query!
Country [259]
0
0
Russian Federation
Query!
State/province [259]
0
0
Moscow
Query!
Country [260]
0
0
Russian Federation
Query!
State/province [260]
0
0
Saint Petersburg
Query!
Country [261]
0
0
Russian Federation
Query!
State/province [261]
0
0
Samara
Query!
Country [262]
0
0
Russian Federation
Query!
State/province [262]
0
0
St.Petersburg
Query!
Country [263]
0
0
Russian Federation
Query!
State/province [263]
0
0
Volgograd
Query!
Country [264]
0
0
Singapore
Query!
State/province [264]
0
0
Singapore
Query!
Country [265]
0
0
Slovakia
Query!
State/province [265]
0
0
Banska Bystrica
Query!
Country [266]
0
0
Slovakia
Query!
State/province [266]
0
0
Bratislava
Query!
Country [267]
0
0
Slovakia
Query!
State/province [267]
0
0
Kosice
Query!
Country [268]
0
0
Slovakia
Query!
State/province [268]
0
0
Nitra
Query!
Country [269]
0
0
Slovenia
Query!
State/province [269]
0
0
Celje
Query!
Country [270]
0
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Slovenia
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Izola
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Ljubljana
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Maribor
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Manises
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Sabadell (Barcelona)
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Santiago de Compostela
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Spain
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Sevilla
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Vizcaya
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Zaragoza
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Gävle
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Göteborg
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Halmstad
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Helsingborg
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Malmö
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Stockholm
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Changhua
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Taoyuan
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Khon Kaen
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Kayseri
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Turkey
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Samsun
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United Kingdom
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Birmingham
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Bournemouth
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Derby
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Dorchester
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Grantham
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High Wycombe
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United Kingdom
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Leicester
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United Kingdom
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Lincoln
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Londonderry
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London
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Middlesbrough
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United Kingdom
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Stoke-on-Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Ethics approval
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Summary
Brief summary
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of
110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate
(DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT)
with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or
ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial
Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary
Syndrome).
The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT
in terms of safety. Safety will be determined by comparing the rates of bleeding events,
assessed using the modified International Society of Thrombosis and Haemostasis
classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02164864
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02164864
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