Apixaban for Valvular heart disease | Aortic bioprosthetic valve replacement

Inclusion criteria

• {"criterion_text":"- 1.\tMale or female ≥18 years of age\n- 2.\tPrior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge\n- 3.\tParticipants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)\n- 4.\tPatients affiliated to social security\n- 5.\tPatient able to give free, informed and written consent"}

Exclusion criteria

• {"criterion_text":"- 1.\tCardiac surgery less than 7 days prior to enrollment or more than 1 month\n- 10.\tKnown hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)\n- 11.\tIschemic stroke within 1 month or intracranial hemorrhage\n- 12.\tActive endocarditis at the time of screening for enrollment.\n- 13.\tWomen of childbearing potential without efficient contraception, pregnant or breastfeeding women.\n- 14.\tConcomitant combined strong P-gp and CYP3A4 inducers or inhibitors.\n- 15.\tHistory of non-compliance\n- 16.\tParticipation in another interventional study\n- 17.\tActive cancer or life expectancy less than 1 year\n- 18.\tPersons deprived of their liberty by judicial or administrative decision\n- 2.\tMechanical valve in any position or combined valve surgery (mitral or tricuspid).\n- 3.\tAny major bleeding in the three months (90 days) prior to enrollment.\n- 4.\tActive 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\n- 5.\tAtrial fibrillation requiring chronic anticoagulation\n- 6.\tNeed 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).\n- 7.\tKnown hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).\n- 8.\tCreatinine clearance <40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.\n- 9.\tKnown 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"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Composite of death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, pulmonary embolism and valve thrombosis; evaluated at end of treatment (105±15 days after inclusion and randomization)."}

Secondary endpoints

• {"endpoint_text":"- Bleeding (primary safety endpoint) : ISTH major bleeding","definition_or_measurement_approach":"Bleeding assessed using ISTH major bleeding definition (primary safety endpoint)."}
• {"endpoint_text":"- Bleeding with ISTH bleeding scale : o\tISTH major bleeding o\tISTH non-major clinically relevant bleeding","definition_or_measurement_approach":"Bleeding categorized by ISTH: major bleeding and non-major clinically relevant bleeding."}
• {"endpoint_text":"- Bleeding with the TIMI bleeding scale : o\tTIMI major bleeding o\tTIMI minor bleeding","definition_or_measurement_approach":"Bleeding categorized by TIMI: major and minor bleeding."}
• {"endpoint_text":"- Bleeding with the BARC definition (BARC 3 to 5)","definition_or_measurement_approach":"Bleeding assessed using BARC classification (BARC 3 to 5)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Individual components of the composite efficacy endpoint as defined (all-cause death; MI by Fourth Universal Definition; stroke; systemic embolism; DVT; PE; valve thrombosis)."}
• {"endpoint_text":"- All-cause death","definition_or_measurement_approach":"Death from any cause."}
• {"endpoint_text":"- Aortic valve thrombosis (adapted from VARC-3 definition)","definition_or_measurement_approach":"Aortic valve thrombosis assessed using an adapted VARC-3 definition."}
• {"endpoint_text":"- Mean aortic gradient (mmHg) and peak velocity (m/s)","definition_or_measurement_approach":"Echocardiographic measurement of mean aortic gradient (mmHg) and peak velocity (m/s)."}

France

Earliest CTIS Part Ii Submission Date

11-03-2025

Latest Decision Or Authorization Date

14-05-2025

Processing Time Days

64

Number Of Sites

26

Number Of Participants

1500

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France