drugset / Trial / NCT02735902

Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)

NCT02735902

Phase 4 Completed 170 enrolled Nîmes University Hospital Medtronic · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC 3 (other complications; Kappetein et al 2012)..

Timeline

Start
2017-06-01
Primary completion
2023-02-02
Completion
2024-01-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 75 mg
Comparator Aspirin Small molecule 100 mg
Background Apixaban Small molecule 2.5 mg
Background Apixaban Small molecule 5 mg
Background Edoxaban Small molecule 30 mg
Background Edoxaban Small molecule 60 mg

Indications

No indication recorded.