DIrect Oral Anticoagulation and Bioprothesis Aortic Valve (NCT05687448) | Clinical Trial Compass
Not Yet RecruitingPhase 3
DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
France1,500 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years of age
✓. Prior implantation of a surgical bioprosthesis in the aortic position at least 7 days and before hospital discharge (excluding TAVI)
✓. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
✓. Patients affiliated to social security
✓. Patient able to give free, informed and written consent
Exclusion criteria
✕. Any cardiac surgery less than 7 days prior to enrollment or more than 1 month
✕. Mechanical valve in any position or combined valve surgery (mitral or tricuspid).
✕. Any major bleeding in the three months (90 days) prior to enrollment.
✕. Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator
✕. Need to be on dual antiplatelet therapy (aspirin \>100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection).
✕. Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).