NCT05687448Not yet recruitingPhase 3
DIrect Oral Anticoagulation and Bioprothesis Aortic Valve
DIrect Oral Anticoagulant for Antithrombotic Management Of Aortic Bioprothesis Valve implaNted Patients for Valvular Heart Disease Study
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 26 Sept 2022
- Start date
- Sept 2025
- Primary completion date
- Sept 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT05687448
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1500
- From Sept 2025 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
- Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
Other illness
- 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
- Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).
- 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
- History of non-compliance
- Active cancer or life expectancy less than 1 year
Lab values
- Creatinine clearance \<40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.
Other
- Atrial fibrillation requiring chronic anticoagulation
- Active endocarditis at the time of screening for enrollment.
- Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
- Participation in another interventional study
- Persons deprived of their liberty by judicial or administrative decision
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Cardiologie Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.