DIAMOND Study - DIrect oral anticoagulant for Antithrombotic Management Of aortic bioprothesis implanted patients for valvular heart Disease Study

Phase 3

Not yet recruiting

Conditions: Aortic bioprothesis implanted patient for valvular heart disease

Registration Number: 2024-516643-64-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: • 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 1500

Inclusion Criteria

Male or female ≥18 years of age
Prior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge
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

Exclusion Criteria

Cardiac surgery less than 7 days prior to enrollment or more than 1 month
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
Participation in another interventional study
Active cancer or life expectancy less than 1 year
Persons deprived of their liberty by judicial or administrative decision
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

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).		The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).

Secondary Outcome Measures

Name	Time	Method
Bleeding (primary safety endpoint) : ISTH major bleeding		Bleeding (primary safety endpoint) : ISTH major bleeding
Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding		Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding
Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding		Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding
Bleeding with the BARC definition (BARC 3 to 5)		Bleeding with the BARC definition (BARC 3 to 5)
Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis		Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis
All-cause death		All-cause death
Aortic valve thrombosis (adapted from VARC-3 definition)		Aortic valve thrombosis (adapted from VARC-3 definition)
Mean aortic gradient (mmHg) and peak velocity (m/s)		Mean aortic gradient (mmHg) and peak velocity (m/s)

Trial Locations

Locations (19): Hopital Saint Joseph
🇫🇷
Marseille, France
Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
CHU Besancon
🇫🇷
Besancon Cedex, France
Nouvelles Cliniques Nimoises
🇫🇷
Nimes, France
CHRU De Nancy
🇫🇷
Vandoeuvre Les Nancy Cedex, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷
Montpellier Cedex 5, France
Centre Hospitalier Universitaire Amiens Picardie
🇫🇷
Amiens Cedex 1, France
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷
Brest, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Pessac Cedex, France
Clinique Pasteur
🇫🇷
Toulouse Cedex 3, France
Scroll for more (9 remaining)
Hopital Saint Joseph
🇫🇷Marseille, France
Thiziri SI MOUSSI
Site contact
33627418855
tsimoussi@hopital-saint-joseph.fr