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DIrect Oral Anticoagulation and Bioprothesis Aortic Valve

NCT05687448 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Guillaume DILLINGER, Professor · Assistance Publique Hôpitaux Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-09-30
Completion
2029-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687448 on ClinicalTrials.gov