DIrect Oral Anticoagulation and mechaNical Aortic Valve
Status:
Not yet recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in
patients (aged ≥18 years) with mechanical aortic valve at least 7 days after cardiac surgery.
Experimental group:
Patients treated with apixaban 5 mg twice daily (BID)
Active Comparator group:
Patients treated with warfarin with an objective of INR target of 2.5 (range: 2.0-3.0)
The Primary objective is To demonstrate that antithrombotic treatment with apixaban is
non-inferior to warfarin (INR target range 2.0 - 3.0) in patients with mechanical heart valve
implanted in the aortic position for at least 7 days for the primary net clinical benefit
endpoint of ischemic outcomes (death, myocardial infarction, stroke, systemic embolism and
valve thrombosis) and bleeding (ISTH major and non-major clinically relevant bleeding).