Status:
COMPLETED
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Lead Sponsor:
St. Antonius Hospital
Conditions:
Aortic Valve Disease
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 a...
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 m...
Eligibility Criteria
Inclusion
- Cohort A
- 1\. Patient has provided written informed consent.
- Cohort B
- Need for long-term oral anticoagulation;
- Patient has provided written informed consent.
Exclusion
- Cohort A
- Need for long-term oral anticoagulation;
- Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- Bare-metal stent implantation within 1 month prior to TAVI procedure;
- Allergy or intolerance to aspirin or clopidogrel.
- Cohort B
- Drug-eluting stent implantation within 3 months prior to TAVI procedure;
- Bare-metal stent implantation within 1 month prior to TAVI procedure;
- Allergy or intolerance to (N)OAC or clopidogrel.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
1016 Patients enrolled
Trial Details
Trial ID
NCT02247128
Start Date
January 1 2014
End Date
April 1 2020
Last Update
April 30 2020
Active Locations (17)
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1
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
2
Onze Lieve Vrouwe Ziekenhuis
Aalst, Belgium
3
Imelda Ziekenhuis
Bonheiden, Belgium
4
Algemeen Ziekenhuis Sint Jan
Bruges, Belgium