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DIAMOND Study - DIrect oral anticoagulant for Antithrombotic Management Of aortic bioprothesis implanted patients for valvular heart Disease Study
EU CTIS ID: 2024-516643-64-00
What this study is testing
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, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female ≥18 years of age
- 2. Prior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge
- 3. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
- 4. Patients affiliated to social security
- 5. Patient able to give free, informed and written consent
You likely can't join if
- 1. Cardiac surgery less than 7 days prior to enrollment or more than 1 month
- 10. Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
- 11. Ischemic stroke within 1 month or intracranial hemorrhage
- 12. Active endocarditis at the time of screening for enrollment.
- 13. Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
- 14. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
See the full eligibility criteria
- 1. Male or female ≥18 years of age
- 2. Prior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge
- 3. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
- 4. Patients affiliated to social security
- 5. Patient able to give free, informed and written consent
- 1. Cardiac surgery less than 7 days prior to enrollment or more than 1 month
- 10. Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
- 11. Ischemic stroke within 1 month or intracranial hemorrhage
- 12. Active endocarditis at the time of screening for enrollment.
- 13. Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
- 14. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
- 15. History of non-compliance
- 16. Participation in another interventional study
- 17. Active cancer or life expectancy less than 1 year
- 18. Persons deprived of their liberty by judicial or administrative decision
- 2. Mechanical valve in any position or combined valve surgery (mitral or tricuspid).
- 3. Any major bleeding in the three months (90 days) prior to enrollment.
- 4. 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
- 5. Atrial fibrillation requiring chronic anticoagulation
- 6. 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).
- 7. Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).
- 8. Creatinine clearance <40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.
- 9. 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.