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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/NCT03023020




Registration number
NCT03023020
Ethics application status
Date submitted
29/12/2016
Date registered
18/01/2017
Date last updated
20/08/2021

Titles & IDs
Public title
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Scientific title
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Secondary ID [1] 0 0
ECRI-009
Universal Trial Number (UTN)
Trial acronym
MASTER DAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Bleeding Risk 0 0
Coronary Artery Disease 0 0
PCI 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aspirin
Treatment: Drugs - P2Y12 inhibitor

Other: Abbreviated antiplatelet regimen - Dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation).
In patients on oral anticoagulants, dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation)

Other: Prolonged antiplatelet regimen - Aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation).
In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)


Treatment: Drugs: Aspirin
Dosing per current guidelines and local practice

Treatment: Drugs: P2Y12 inhibitor
Dosing per current guidelines and local practice
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
Timepoint [1] 0 0
11 months
Primary outcome [2] 0 0
Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
Timepoint [2] 0 0
11 months
Primary outcome [3] 0 0
Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Timepoint [3] 0 0
11 months
Secondary outcome [1] 0 0
All cause death
Timepoint [1] 0 0
14 months
Secondary outcome [2] 0 0
Death from cardiovascular causes
Timepoint [2] 0 0
14 months
Secondary outcome [3] 0 0
Myocardial infarction
Timepoint [3] 0 0
14 months
Secondary outcome [4] 0 0
Stroke
Timepoint [4] 0 0
14 months
Secondary outcome [5] 0 0
Bleeding events
Timepoint [5] 0 0
14 months
Secondary outcome [6] 0 0
Definite or probable stent thrombosis
Timepoint [6] 0 0
14 months
Secondary outcome [7] 0 0
Any target vessel revascularization
Timepoint [7] 0 0
14 months
Secondary outcome [8] 0 0
Urgent target vessel revascularization
Timepoint [8] 0 0
14 months
Secondary outcome [9] 0 0
Urgent non-target vessel revascularization
Timepoint [9] 0 0
14 months
Secondary outcome [10] 0 0
Clinically indicated non-target vessel revascularization
Timepoint [10] 0 0
14 months
Secondary outcome [11] 0 0
Transfusion rates both in patients with and/or without clinically detected over bleeding
Timepoint [11] 0 0
14 months

Eligibility
Key inclusion criteria
After index PCI, patients aged 18 years or more are eligible for inclusion into the study
if the following criteria are met.

1. At least one among the HBR criteria (as defined below) is met.

2. All lesions are successfully treated with Ultimaster stent in the context of routine
clinical care, i.e. post-procedural angiographic diameter stenosis <20% by visual
estimation

3. Free from any flow-limiting angiographic complications (i.e. significant untreated
dissection or major side-branch occlusion), which require prolonged DAPT duration
based on operator's opinion.

4. All stages of PCI are complete (if any) and no further PCI is planned.

At randomization visit (one month after index PCI), the following criteria must be met:

1. Fulfilment of at least one HBR criterion (as defined below), or on the basis of
post-PCI actionable (i.e. requiring medical attention) non-access site related
bleeding episode

2. Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic
restenosis, stent thrombosis, stroke and any revascularization (coronary and
non-coronary) requiring prolonged DAPT

3. If not on OAC,

1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor

2. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching
between oral P2Y12 inhibitors has occurred in the previous 7 days)

4. If on OAC

1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at
least 7 days

2. Patient is on clopidogrel for at least 7 days

Definition of HBR

Post-PCI patients are at HBR if at least one of the following criteria applies:

- Clinical indication for treatment with oral anticoagulants (OAC) for at least 12
months

- Recent (<12 months) non-access site bleeding episode(s), which required medical
attention (i.e. actionable bleeding).

- Previous bleeding episode(s) which required hospitalization if the underlying cause
has not been definitively treated (i.e. surgical removal of the bleeding source)

- Age equal or greater than 75 years

- Systemic conditions associated with an increased bleeding risk (e.g. haematological
disorders, including a history of or current thrombocytopaenia defined as a platelet
count <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with
increased bleeding risk.

- Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion
within 4 weeks before randomization.

- Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs

- Diagnosed malignancy (other than skin) considered at high bleeding risk including
gastro-intestinal, genito-urethral/renal and pulmonary.

- Stroke at any time or TIA in the previous 6 months

- PRECISE DAPT score of 25 or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treated with stents other than Ultimaster stent within 6 months prior to index
procedure

2. Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months
before

3. Treated with a bioresorbable scaffold at any time prior to index procedure

4. Cannot provide written informed consent

5. Under judicial protection, tutorship or curatorship

6. Unable to understand and follow study-related instructions or unable to comply with
study protocol

7. Active bleeding requiring medical attention (BARC=2) on randomization visit

8. Life expectancy less than one year

9. Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel,
cobalt chromium or sirolimus

10. Any planned and anticipated PCI

11. Participation in another trial

12. Pregnant or breast feeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2021
Sample size
Target
Accrual to date
Final
4579
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [3] 0 0
Research Center Perth - Perth
Recruitment hospital [4] 0 0
Research Center Sydney - Sydney
Recruitment hospital [5] 0 0
Wollongong Research Center - Wollongong
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
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Buenos Aires
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Austria
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Wien
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Bahrain
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Manama
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Bangladesh
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Dhaka
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Belgium
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Aalst
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Belgium
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Bonheiden
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Hasselt
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Belgium
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Liège
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Czechia
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Brno
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Czechia
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Praha
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Denmark
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Roskilde
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Estonia
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Tallinn
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France
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Annecy
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France
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Caen
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France
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Créteil
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France
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Dijon
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France
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Marseille
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France
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Massy
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France
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Metz
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France
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Montauban
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France
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Montpellier
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France
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Nantes
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France
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Nîmes
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France
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Paris
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France
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Rouen
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France
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Saint-Denis
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Germany
State/province [31] 0 0
Homburg
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Germany
State/province [32] 0 0
Landshut
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
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India
State/province [35] 0 0
Chennai
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India
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Coimbatore
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India
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Surat
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah tikva
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Israel
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Safed
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Italy
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Andria
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Italy
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Cagliari
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Italy
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Caserta
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Italy
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Catania
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Italy
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Messina
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Italy
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Milan
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Italy
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Treviglio
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Italy
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Vimercate
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Fukuoka
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Gifu
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Ichinomiya
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Kawasaki
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Nagakute
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Nagoya
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Osaka
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Tokyo
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Japan
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Toyoake
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Korea, Republic of
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Seoul
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Netherlands
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's Hertogenbosch
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Arnhem
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Breda
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Dordrecht
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Eindhoven
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Emmen
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Enschede
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Nieuwegein
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Rotterdam
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Terneuzen
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The Hague
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North Macedonia
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Skopje
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Poland
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Krakow
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Kraków
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Lubin
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Poznan
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Wroclaw
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Saudi Arabia
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Jeddah
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Riyadh
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Singapore
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Singapore
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Slovenia
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Ljubljana
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Alicante
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Barcelona
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Spain
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El Palmar
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Huelva
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Spain
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Madrid
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Spain
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Santander
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Spain
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Vigo
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Sweden
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Gävle
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Sweden
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Örebro
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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Geneva
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Switzerland
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Liestal
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Switzerland
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Lugano
Country [100] 0 0
Switzerland
State/province [100] 0 0
Zürich
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Blackburn
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Bournemouth
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Brighton
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Bristol
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Derry
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Manchester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Newcastle Upon Tyne
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Stevenage
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Stoke-on-Trent
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Wolverhampton
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Worcester
Country [113] 0 0
Vietnam
State/province [113] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ECRI bv
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Cardialysis B.V.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Cardiovascular Research Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Bern
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Terumo Medical Corporation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study compares two lengths of medication therapy (a shortened versus a prolonged dual
antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the
successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more
likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are
within the current medical recommendations. The aim of this study is to help improve further
standard antiplatelet duration guidelines.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03023020
Trial related presentations / publications
Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016
Public notes

Contacts
Principal investigator
Name 0 0
M. Valgimigli, Prof.
Address 0 0
Cardiocentro Ticino Foundation, Lugano, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03023020