Aortic Valve Disease, Bleeding, Myocardial Infarction, Stroke
Conditions
Keywords
Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Disease, Aortic Stenosis, Myocardial Infarction, Ischemic stroke, Bleeding, Thrombosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Embolism and Thrombosis, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Antithrombotic treatment, Oral anticoagulation, Warfarin, Platelet Aggregation Inhibitors, Genetic Testing, Cytochrome P450 2C19 (CYP2C19), Prostaglandin-endoperoxide synthase 2(PTGS2)
Brief summary
At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk. We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).
Detailed description
The trial consists of two cohorts: * Cohort A, patients without an indication for OAC prior to TAVI. * Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).
Interventions
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 to (N)OAC or clopidogrel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Net-clinical benefit endpoint | 1 year | 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. |
| Efficacy endpoint | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacoeconomics endpoint | 1 year | Outcome measure is quality-adjusted life years |
Countries
Belgium, Czechia, Luxembourg, Netherlands
Outcome results
None listed