DIrect Oral Anticoagulation and Bioprothesis Aortic Valve

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 6, 2023

Keywords

ClinConnect Summary

The DIAMOND study is a clinical trial that is looking at two different blood-thinning medications—apixaban and warfarin—in patients who have had a mechanical aortic valve placed in their heart. This study aims to find out if apixaban is just as effective as warfarin in preventing serious health problems, like heart attacks or strokes, and in managing any bleeding risks. To participate, you need to be at least 18 years old, have received a mechanical aortic valve at least a week before, and currently be on blood-thinning treatment that can include either of these medications.

If you join the trial, you'll be randomly assigned to take either apixaban (5 mg twice a day) or warfarin (with a target blood measurement called INR between 2.0 and 3.0). The study is not yet recruiting participants, but it's important to know that certain health conditions, like recent surgery or specific bleeding risks, may prevent you from being eligible. Overall, this trial could provide valuable information on the best way to manage blood-thinning treatment for patients with mechanical heart valves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ≥18 years of age
• • 2. Prior implantation of a surgical bioprosthesis in the aortic position at least 7 days and before hospital discharge (excluding TAVI)
• • 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
• Exclusion Criteria:
• • 1. Any cardiac surgery less than 7 days prior to enrollment or more than 1 month
• • 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
• • 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