No registrations found.
ID
Source
Brief title
Health condition
Aortic valve disease; aortic valve stenosis; bleeding; stroke; thrombosis; platelet inhibitors.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
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.
Study objective
Monotherapy with aspirin or oral anticoagulation after TAVI is safer than the addition of clopidogrel for 3 months, without being less clinically beneficial.
Study design
30 days, 3 months, 6 months, and 12 months after TAVI.
Intervention
Cohort 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.
J.M. ten Berg
[default]
The Netherlands
+31 88 320 1121
j.ten.berg@antoniusziekenhuis.nl
J.M. ten Berg
[default]
The Netherlands
+31 88 320 1121
j.ten.berg@antoniusziekenhuis.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4796 |
| NTR-old | NTR4936 |
| Other | : NCT02247128 |