NCT02735902

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

Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)..

Detailed description

The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups: 1. Mortality (all causes). 2. Cardiovascular mortality. 3. The occurrence of myocardial infarction. 4. The occurrence of stroke. 5. The occurrence of valve thrombosis. 6. The occurrence of major bleeding (BARC ≥ 3). 7. The occurrence of minor bleeding (2 ≤ BARC \<3). 8. Treatment compliance.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DRUG	Vitamin K antagonist or direct oral anticoagulant treatment	The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK. The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg
DRUG	Aspirin	Daily dose is between 75 mg and 100 mg. Allergic reactions to aspirin may be observed in rare cases. In case of suspicion of allergy, treatment with aspirin is stopped.

Timeline

• Start date: 2017-06-01
• Primary completion: 2023-02-02
• Completion: 2024-01-19
• First posted: 2016-04-13
• Last updated: 2024-07-24

Locations

6 sites across 1 country: France