drugset / Trial / NCT05687448
DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09
- Primary completion
- 2025-09
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Comparator | Aspirin | Small molecule | 75 mg | — |
| Comparator | Aspirin | Small molecule | 100 mg | — |