Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Treatments: Aspirin; Clopidogrel; Platelet Aggregation Inhibitors; Ticlopidine

Criteria

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.