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Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation


- candidate number21007
- NTR NumberNTR4936
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-nov-2014
- Secondary IDsNCT02247128 
- Public TitleAntiplatelet therapy for patients undergoing transcatheter aortic valve implantation
- Scientific TitleAntiplatelet therapy for patients undergoing transcatheter aortic valve implantation
- ACRONYMPOPular TAVI
- hypothesisMonotherapy with aspirin or oral anticoagulation after TAVI is safer than the addition of clopidogrel for 3 months, without being less clinically beneficial.
- Healt Condition(s) or Problem(s) studiedBleeding, Aortic valve stenosis, Thrombosis, Stroke, Platelet inhibitors
- Inclusion criteriaCohort A 1. Patient has provided written informed consent. Cohort B 2. Need for long-term oral anticoagulation; 3. Patient has provided written informed consent.
- Exclusion criteriaCohort A 1. Need for long-term oral anticoagulation; 2. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 3. Bare-metal stent implantation within 1 month prior to TAVI procedure; 4. Allergy or intolerance to aspirin or clopidogrel. Cohort B 1. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 2. Bare-metal stent implantation within 1 month prior to TAVI procedure; 3. Use of non-vitamin K oral anticoagulation (NOAC); 4. Allergy or intolerance to OAC or clopidogrel.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-aug-2017
- Target number of participants1000
- InterventionsCohort A Random 1:1 allocation to aspirin alone (at least until 1 year) (intervention) versus clopidogrel (3 months) + aspirin (at least until 1 year) (control), 1 day before TAVI in patients without an indication for OAC at baseline; Cohort B Random 1:1 allocation to OAC alone (intervention) versus OAC + clopidogrel (3 months) (control), 1 day before TAVI in patients with an indication for OAC at baseline.
- Primary outcomeThe primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).
- Secondary outcomeThe secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI. The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI.
- Timepoints30 days, 3 months, 6 months, and 12 months after TAVI.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.M. ten Berg
- CONTACT for SCIENTIFIC QUERIESDr. J.M. ten Berg
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-nov-2014 - 4-feb-2015


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