DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
ConditionAortic Valve Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Apixaban 5 MG Oral Tablet
- Aspirin 75 to 100mg once a day
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov