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NOT YET RECRUITING
NCT05687448
PHASE3

DIrect Oral Anticoagulation and Bioprothesis Aortic Valve

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

DRUG

Apixaban 5 MG Oral Tablet

Patients treated with apixaban 5 mg twice daily (BID)

DRUG

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