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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Apixaban 5 MG Oral Tablet

    Drug

    Patients treated with apixaban 5 mg twice daily (BID)

  • Aspirin 75 to 100mg once a day

    Drug

    Patients treated with Aspirin 75 to 100mg once a day

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Active Comparator group:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Clinical Events (MACE)

The primary endpoint is a composite efficacy endpoint including death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis.

Time frame
Up to 3.5 months

Secondary outcomes

1

Bleeding

ISTH major and non-major clinically relevant bleeding

Time frame
Up to 3.5 months
2

Death

Including cardiovascular and non cardiovascular death

Time frame
Up to 3.5 months
3

Myocardial infarction

Time frame
Up to 3.5 months
4

Stroke

Time frame
Up to 3.5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: