Antiplatelet therapy for patients undergoing transcatheter aortic valve implantatio

Recruiting

Conditions: Aortic valve disease
aortic valve stenosis
bleeding
stroke
thrombosis
platelet inhibitors.

Registration Number: NL-OMON25546

Lead Sponsor: St Antonius Hospital, Nieuwegein, the Netherlands

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

Cohort 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 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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The 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 Outcome Measures

Name	Time	Method
The 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.<br><br>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.