DIrect Oral Anticoagulation and Bioprothesis Aortic Valve

NCT05687448 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2024-516643-64-00
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anticoagulant; Aortic valve; Apixaban; Aspirin; Stroke; Hemorrhage

Outcome Measures

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.

  Up to 3.5 months

Secondary Outcomes (12)

• Bleeding

  Up to 3.5 months

• Death

  Up to 3.5 months

• Myocardial infarction

  Up to 3.5 months

• Stroke

  Up to 3.5 months

• Systemic embolism

  Up to 3.5 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients treated with apixaban 5 mg twice daily (BID)

Drug: Apixaban 5 MG Oral Tablet

Active Comparator group:

ACTIVE COMPARATOR

Patients treated with Aspirin 75 to 100mg once a day

Drug: Aspirin 75 to 100mg once a day

Interventions

Apixaban 5 MG Oral Tablet DRUG

Patients treated with apixaban 5 mg twice daily (BID)

Also known as: Experimental Group

Experimental Group

Aspirin 75 to 100mg once a day DRUG

Patients treated with Aspirin 75 to 100mg once a day

Also known as: Active Comparator

Active Comparator group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Atrial fibrillation requiring chronic anticoagulation
• 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).
• Creatinine clearance \<40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.
• Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure
• Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
• Ischemic stroke within 1 month or intracranial hemorrhage
• Active endocarditis at the time of screening for enrollment.
• Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
• Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
• History of non-compliance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Cardiologie Hôpital Lariboisière

Paris, Paris, 75010, France

Location

MeSH Terms

Conditions

Aortic Valve Disease; Stroke; Hemorrhage

Interventions

apixaban; Tablets

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jean-Guillaume DILLINGER, Professor

  Assistance Publique Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Guillaume DILLINGER, Professor

CONTACT

+33 1 49 95 86 74; jean-guillaume.dillinger@aphp.fr

Bernard IUNG, Professor

CONTACT

+33 1 40 25 66 01; bernard.iung@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The Outcomes adjudication will be performed blinded of patients treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis 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

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: January 18, 2023
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)