Monotherapy with aspirin or oral anticoagulation after TAVI is safer than the addition of clopidogrel for 3 months, without being less clinically beneficial.
ID
Bron
Verkorte titel
Aandoening
Aortic valve disease; aortic valve stenosis; bleeding; stroke; thrombosis; platelet inhibitors.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Doel van het onderzoek
Monotherapy with aspirin or oral anticoagulation after TAVI is safer than the addition of clopidogrel for 3 months, without being less clinically beneficial.
Onderzoeksopzet
30 days, 3 months, 6 months, and 12 months after TAVI.
Onderzoeksproduct en/of interventie
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.
Publiek
J.M. ten Berg
[default]
The Netherlands
+31 88 320 1121
j.ten.berg@antoniusziekenhuis.nl
Wetenschappelijk
J.M. ten Berg
[default]
The Netherlands
+31 88 320 1121
j.ten.berg@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4796 |
| NTR-old | NTR4936 |
| Ander register | : NCT02247128 |