Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation "POPular-TAVI"

Recruiting

Phase 4 Results N/A

Trial Description

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).

Conditions

Interventions

  • Aspirin + clopidogrel Drug
    ARM 1: Kind: Experimental
    Label: Aspirin + Clopicogrel (Cohort A)
    Description: Cohort A: patients will receive clopidogrel (75mg quaque die (qD), 3 months) on top of low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patient in Cohort A doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI.
  • Aspirin monotherapy Drug
    ARM 1: Kind: Experimental
    Label: Aspirin monotherapy (Cohort A)
    Description: Cohort A: patients will receive low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patients doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.
  • OAC + clopicogrel Drug
    ARM 1: Kind: Experimental
    Label: OAC + Clopicogrel (Cohort B)
    Description: Cohort B: patients will receive clopidogrel (75mg qD, 3 months) on top of OAC (according to its indication). The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. aspirin) at least 5 days prior to the TAVI procedure.
  • OAC monotherapy Drug
    ARM 1: Kind: Experimental
    Label: OAC monotherapy (Cohort B)
    Description: Cohort B: patients will receive OAC according to its indication. It is recommended to continue the OAC therapy peri-procedural (International Normalized Ratio aimed at 2.0). It is recommended to omit antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety endpoint 1 year Yes
Secondary Net-clinical benefit endpoint 1 year Yes
Secondary Efficacy endpoint 1 year Yes

Sponsors