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DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery. Experimental group: Patients treated with apixaban 5 mg twice daily (BID) Active Comparator group: Aspirin 75 to 100mg once a day The primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.
Official title: DIrect Oral Anticoagulant for Antithrombotic Management Of Aortic Bioprothesis Valve implaNted Patients for Valvular Heart Disease Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2025-09
Completion Date
2029-03
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Apixaban 5 MG Oral Tablet
Patients treated with apixaban 5 mg twice daily (BID)
Aspirin 75 to 100mg once a day
Patients treated with Aspirin 75 to 100mg once a day
Locations (1)
Service de Cardiologie Hôpital Lariboisière
Paris, Paris, France