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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02239120
Registration number
NCT02239120
Ethics application status
Date submitted
10/09/2014
Date registered
12/09/2014
Date last updated
6/09/2019
Titles & IDs
Public title
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Query!
Scientific title
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
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Secondary ID [1]
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0
2013-003444-24
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Secondary ID [2]
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0
1160.189
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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:
Stroke
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0
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Secondary Prevention
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0
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Condition category
Condition code
Stroke
0
0
0
0
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Haemorrhagic
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Stroke
0
0
0
0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - optional ASA as comedication
Treatment: Drugs - placebo to ASA
Treatment: Drugs - placebo to optional ASA as comedication
Treatment: Drugs - placebo to dabigatran etexilate
Treatment: Drugs - ASA 100 mg
Treatment: Drugs - dabigatran etexilate
Experimental: dabigatran etexilate 110 or 150 mg - Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)
Active comparator: ASA 100 mg - All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d
Treatment: Drugs: optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
Treatment: Drugs: placebo to ASA
placebo to comparator drug
Treatment: Drugs: placebo to optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
Treatment: Drugs: placebo to dabigatran etexilate
placebo
Treatment: Drugs: ASA 100 mg
active comparator drug
Treatment: Drugs: dabigatran etexilate
active drug
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Intervention code [1]
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0
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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Adjudicated Recurrent Stroke
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Assessment method [1]
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Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [1]
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From randomisation until full follow up period, approximately 43 months.
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Primary outcome [2]
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First Major Bleed (Adjudicated)
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Assessment method [2]
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First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:
* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,
* Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of =2 units of blood or packed cells (equivalent to =4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,
* Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [2]
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Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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Secondary outcome [1]
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Adjudicated Ischaemic Stroke
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Assessment method [1]
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Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [1]
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From randomisation until full follow up period, up to 43 months
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Secondary outcome [2]
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Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death
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Assessment method [2]
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Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [2]
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From randomisation until full follow up period, up to 43 months
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Secondary outcome [3]
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Disabling Stroke
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Assessment method [3]
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Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [3]
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From randomisation until full follow up period, up to 43 months
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Secondary outcome [4]
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All-cause Death
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Assessment method [4]
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All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [4]
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From randomisation until full follow up period, up to 43 months
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Secondary outcome [5]
0
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Adjudicated Intracranial Hemorrhage
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Assessment method [5]
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Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.
The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [5]
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Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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Secondary outcome [6]
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Adjudicated Fatal Bleed
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Assessment method [6]
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Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.
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Timepoint [6]
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Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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Secondary outcome [7]
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Adjudicated Life-threatening Bleed
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Assessment method [7]
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Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.
The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [7]
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Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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Secondary outcome [8]
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Any Bleed (Investigator-reported)
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Assessment method [8]
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This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.
The annualised event rate represents the average number of events per patient during a 1-year period.
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Timepoint [8]
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Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset.
* The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke.
* Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia.
* As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes).
Further inclusion criteria apply.
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Minimum age
18
Years
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Maximum age
150
Years
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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:
* Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications.
* Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis.
* Any indication that requires treatment with an anticoagulant as per Investigator's judgment.
* History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).
* Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse).
* Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study.
Further exclusion criteria apply.
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Study design
Purpose of the study
Prevention
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Single group
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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
27/11/2014
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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
14/08/2018
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Sample size
Target
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Accrual to date
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Final
5390
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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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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [3]
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Kanwal Medical Complex - Kanwal
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Recruitment hospital [4]
0
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John Hunter Hospital - New Lambton
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Recruitment hospital [5]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [6]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [7]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Calvary North Adelaide Hospital - Adelaide
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Recruitment hospital [10]
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Box Hill Hospital - Box Hill
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Recruitment hospital [11]
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Austin Health - Heidelberg
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Recruitment hospital [12]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [13]
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Alfred Health - Victoria
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2259 - Kanwal
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Recruitment postcode(s) [4]
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2305 - New Lambton
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Recruitment postcode(s) [5]
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2038 - St Leonards
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Recruitment postcode(s) [6]
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4575 - Birtinya
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Recruitment postcode(s) [7]
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4029 - Herston
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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5001 - Adelaide
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Recruitment postcode(s) [10]
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3128 - Box Hill
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Recruitment postcode(s) [11]
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3084 - Heidelberg
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Recruitment postcode(s) [12]
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3050 - Parkville
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Recruitment postcode(s) [13]
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3004 - Victoria
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Recruitment outside Australia
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Arizona
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Connecticut
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Qingdao
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Shanghai
Query!
Country [86]
0
0
China
Query!
State/province [86]
0
0
Shenyang
Query!
Country [87]
0
0
China
Query!
State/province [87]
0
0
Xiamen
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Xuzhou
Query!
Country [89]
0
0
Colombia
Query!
State/province [89]
0
0
Bogotá
Query!
Country [90]
0
0
Colombia
Query!
State/province [90]
0
0
Cali
Query!
Country [91]
0
0
Colombia
Query!
State/province [91]
0
0
Floridablanca
Query!
Country [92]
0
0
Croatia
Query!
State/province [92]
0
0
Varazdin
Query!
Country [93]
0
0
Croatia
Query!
State/province [93]
0
0
Zagreb
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Brno
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Jihlava
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Olomouc
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Ostrava
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Prague 5
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Praha 5
Query!
Country [100]
0
0
Estonia
Query!
State/province [100]
0
0
Ahtme
Query!
Country [101]
0
0
Estonia
Query!
State/province [101]
0
0
Tallinn
Query!
Country [102]
0
0
Estonia
Query!
State/province [102]
0
0
Tartu
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Aix en Provence
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Bayonne
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Besançon
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Bordeaux
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Brest
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Bron
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Caen
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Grenoble
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Lille
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Metz
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Paris
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Toulouse
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Altenburg
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Bad Neustadt
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Berlin
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Bielefeld
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Bochum
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Bremen
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Buchholz
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Celle
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Chemnitz
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Coburg
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Dortmund
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Dresden
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Düsseldorf
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Erlangen
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Essen
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Frankfurt am Main
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Frankfurt
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Friedrichshafen
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Fulda
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Gelsenkirchen
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Gera
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Gießen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Greifswald
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Günzburg
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Hamburg
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Hanau
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Hannover
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Heidelberg
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Heilbronn
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Idar-Oberstein
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Jena
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Kiel
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Köln
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Leipzig
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Ludwigshafen
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Magdeburg
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Mainz
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Marburg
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Meißen
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Minden
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Moenchengladbach
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Mühlhausen
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
München
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Münster
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Nürnberg
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Offenbach
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Osnabrück
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Regensburg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Sande
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Siegen
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Stuttgart
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Teupitz
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Trier
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Tübingen
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Ulm
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Weimar
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Wiesbaden
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Würzburg
Query!
Country [173]
0
0
Greece
Query!
State/province [173]
0
0
Alexandroupolis
Query!
Country [174]
0
0
Greece
Query!
State/province [174]
0
0
Athens
Query!
Country [175]
0
0
Greece
Query!
State/province [175]
0
0
Herakleion
Query!
Country [176]
0
0
Greece
Query!
State/province [176]
0
0
Larissa
Query!
Country [177]
0
0
Greece
Query!
State/province [177]
0
0
Patras
Query!
Country [178]
0
0
Greece
Query!
State/province [178]
0
0
Thessaloniki
Query!
Country [179]
0
0
Hong Kong
Query!
State/province [179]
0
0
Hong Kong
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Budapest
Query!
Country [181]
0
0
Hungary
Query!
State/province [181]
0
0
Debrecen
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Kistarcsa
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Miskolc
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Pecs
Query!
Country [185]
0
0
India
Query!
State/province [185]
0
0
Bangalore
Query!
Country [186]
0
0
India
Query!
State/province [186]
0
0
Chandigarh
Query!
Country [187]
0
0
India
Query!
State/province [187]
0
0
Guntur
Query!
Country [188]
0
0
India
Query!
State/province [188]
0
0
Hyderabad
Query!
Country [189]
0
0
India
Query!
State/province [189]
0
0
Karamsad
Query!
Country [190]
0
0
India
Query!
State/province [190]
0
0
Kottayam
Query!
Country [191]
0
0
India
Query!
State/province [191]
0
0
Mangalore
Query!
Country [192]
0
0
India
Query!
State/province [192]
0
0
Mumbai
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Nashik
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
New Delhi
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Pune
Query!
Country [196]
0
0
Israel
Query!
State/province [196]
0
0
Hadera
Query!
Country [197]
0
0
Israel
Query!
State/province [197]
0
0
Holon
Query!
Country [198]
0
0
Israel
Query!
State/province [198]
0
0
Tel Hashomer, Ramat Gan
Query!
Country [199]
0
0
Israel
Query!
State/province [199]
0
0
Telaviv
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Avezzano
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Bologna
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Brescia
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Cona (FE)
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Genova
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Messina
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Milano
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Modena
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Padova
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Perugia
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Piacenza
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Pietra Ligure
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Roma
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Siena
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Torino
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Treviso
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Varese
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Verona
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Aichi, Nagoya
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Aichi, Toyohashi
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Aichi, Toyota
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Akita, Akita
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Chiba, Urayasu
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Fukuoka, Chikushi-gun
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Fukuoka, Chikushino
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Fukuoka, Fukuoka
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Fukuoka, Kasuga
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Fukuoka, Kitakyushu
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Fukuoka, Kurume
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Fukuoka, Onga
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Fukuoka, Tagawa
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Fukuoka, Yukuhashi
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Fukushima, Date-Gun
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Fukushima, Nihonmatsu
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Gifu, Gifu
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Gifu, Takayama
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Gunma, Isesaki
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Gunma, Maebashi
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Hiroshima, Hiroshima
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Hokkaido, Sapporo
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Hyogo, Kobe
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Ibaraki, Toride
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Ibaraki, Tsukuba
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Iwate, Morioka
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Kagoshima, Kagoshima
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Kanagawa, Kamakura
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Kumamoto, Kumamoto
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Kyoto, Uji
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Miyagi, Sendai
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Miyagi, Shibata-gun
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Nagano, Ina
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Nagano, Naganoi
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Nagasaki, Nagasaki
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Osaka, Daito
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Osaka, Higashiosaka
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Osaka, Izumisano
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Osaka, Kishiwada
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Osaka, Osaka
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Osaka, Suita
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Saitama, Asaka
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Saitama, Hidaka
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Saitama, Saitama
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Tokyo, Bunkyo-ku
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Tokyo, Itabashi-ku
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Tokyo, Mitaka
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Tokyo, Shinjuku-ku
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Wakayama, Wakayama
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Yamagata, Yamagata
Query!
Country [268]
0
0
Korea, Republic of
Query!
State/province [268]
0
0
Anyang
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Funding & Sponsors
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Boehringer Ingelheim
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Summary
Brief summary
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).
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Trial website
https://clinicaltrials.gov/study/NCT02239120
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Trial related presentations / publications
Del Brutto VJ, Diener HC, Easton JD, Granger CB, Cronin L, Kleine E, Grauer C, Brueckmann M, Toyoda K, Schellinger PD, Lyrer P, Molina CA, Chutinet A, Bladin CF, Estol CJ, Sacco RL. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial. J Am Heart Assoc. 2022 Jun 7;11(11):e023545. doi: 10.1161/JAHA.121.023545. Epub 2022 Jun 3. Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10. Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15. Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16. Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28. Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinova Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Sanak D, Schabitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14. Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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No information has been provided regarding IPD availability
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Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/20/NCT02239120/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/20/NCT02239120/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02239120
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