Antiplatelet therapy for patients undergoing transcatheter aortic valve implantatio
Phase 4
Completed
- Conditions
- Aortic valve disease1004697310007593
- Registration Number
- NL-OMON45158
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Cohort A
1. Patient has provided written informed consent.;Cohort B
1. Need for long-term oral anticoagulation;
2. Patient has provided written informed consent.
Exclusion Criteria
Cohort 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 or contraindication 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. Allergy or intolerance or contraindication to OAC or clopidogrel.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary safety outcome is defined as all and non-procedure related bleeding<br /><br>(primarily classified according to BARC(Mehran et al., 2011) and also TIMI(Mega<br /><br>et al., 2009; Sabatine et al., 2009) and GUSTO(The GUSTO Investigators, 1993)).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary net-clinical benefit outcome is a composite of cardiovascular<br /><br>mortality, non-procedural bleeding, stroke, and myocardial infarction.<br /><br>Secondary efficacy outcome is a composite of cardiovascular mortality, ischemic<br /><br>stroke, and myocardial infarction.<br /><br><br /><br>Furthermore, we will register the composites of the primary and secondary<br /><br>outcomes, all-cause mortality, rehospitalisation and time to rehospitalisation,<br /><br>vascular complication (VC), number of blood transfusions, cardiac tamponade,<br /><br>transient ischemic attack (TIA), acute kidney injury, myocardial infarction and<br /><br>damage, prosthetic valve thrombosis, transvalvular aortic gradients, effective<br /><br>aortic valve area, paravalvular regurgitation, NYHA functional classification,<br /><br>combined early safety according to the VARC-2 Consensus(Kappetein et al.,<br /><br>2012), cost-effectiveness, frailty, and quality of life.</p><br>