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

Recruiting

Phase 4 Results N/A

Update History

31 Jan '18
The Summary of Purpose was updated.
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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).
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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).
The eligibility criteria were updated.
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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.
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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. Use of non-vitamin K oral anticoagulation (NOAC); 4. Allergy or intolerance to OAC or clopidogrel.
A location was updated in Utrecht.
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The overall status was updated to "Recruiting" at University Medical Center Utrecht (UMCU).
26 Apr '17
The gender criteria for eligibility was updated to "All."
A location was updated in Amsterdam.
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The overall status was updated to "Recruiting" at Academic Medical Centre (AMC).
A location was updated in Zwolle.
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The overall status was updated to "Recruiting" at Isala Clinics.
A location was updated in Maastricht.
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The overall status was updated to "Recruiting" at Academic Hospital.
15 Oct '14
Trial acronym was updated.
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POPular-TAVI