API-AHAI - Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
- Conditions
- autoimmune hemolytic anemiaMedDRA version: 20.0Level: LLTClassification code: 10003825Term: Autoimmune hemolytic anemia Class: 10005329Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-513191-17-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Dijon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Patient who provided free, written and informed consent, Patient aged = 18 years, Patient with a diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) (infections, hematologic diseases, systemic diseases), according to the following criteria: - Hemoglobin <12 g/dL - and decreased haptoglobin (<0,4 g/L) - and positive direct antiglobulin test (direct Coombs test) (IgG +/- C3d), Newly diagnosed or relapsed patient (relapse is defined as a decrease in basal hemoglobin in association with AIHA - thus meeting the above criteria: Hb <12 g/dl and haptoglobin <0.4 g/L and IgG-positive TDA with or without C3d - and for whom the investigator deems it necessary to initiate etiological treatment specific to AIHA), Patient with an estimated life expectancy of more than 6 months
Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic CT angiography or pulmonary scintigraphy)., Patients with a contraindication to enoxaparin: - hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low-molecular-weight heparins (LMWH), or to any of the excipients, - history of heparin-induced thrombocytopenia, Patient with cold agglutinin-related AIHA (C3d-positive ADT alone with identification of cold agglutinins), Patient with severe hemostasis disorders: - hypofibrinogenemia < 2 g/L, - disseminated intravascular coagulation (APTT prolongation >1.2, and PT <50%, and thrombocytopenia <100 G/L, and D-Dimer >500 µg/L) - hemophilia, Patient whose clinical condition requires hospitalization in an intensive care unit, Patient who has already participated in the study, Patient not affiliated to national health insurance, Patient under legal protection (curatorship, guardianship), Patient subject to a court order, Pregnant, parturient or breastfeeding women, Patient with physiological capacity to procreate (having had her first menstrual period and not menopausal and not presenting permanent sterility (hysterectomy, bilateral salpingectomy, bilateral oophorectomy)) and unable to have effective contraception (i.e., provided by an estrogenprogestin oral contraceptive or progestogen, a contraceptive implant, an intrauterine device or a tubal ligation), Patients on curative anticoagulation (VTE, atrial fibrillation), Patient of legal age who is unable to provide consent, Patient on dual antiplatelet treatment, Patient with active bleeding, Patient with a known condition or lesion at risk of bleeding, Patient with ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion, Patient on preventive anticoagulation for 14 days or more, Patient with a contraindication to apixaban: - Known hypersensitivity to the molecule or to any of the excipients, - thrombocytopenia <100 G/L, - kidney failure (glomerular filtration rate < 30 ml/min/1.73m²), - Active liver disease (liver failure defined as Factor V <50% or INR >1.5, ALT elevation >2 times the upper limit of normal), Patients receiving concomitant treatment with potent CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) or potent CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these treatments cannot be discontinued or modified.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of prolonged prophylactic anticoagulation for 12 weeks with heparin therapy (enoxaparin 4000 IU/day subcutaneously) during hospitalization followed by oral anticoagulation with apixaban (2.5 mg morning and evening), on the occurrence of venous thromboembolism (VTE) at 24 weeks in patients with warm-type autoantibody AIHA at diagnosis or relapse.;Secondary Objective: Describe the time to onset of thromboembolic events, Study the tolerability of apixaban in prophylactic doses, Describe biological markers of thromboembolic risk in AIHA, Exploratory: compare VTE frequency and time to onset between intervention and standard arms;Primary end point(s): Occurrence of clinical venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE)) within 24 weeks of randomization defined by the presence of DVT confirmed by venous Doppler and/or PE confirmed by thoracic CT angiography or ventilation/perfusion lung scintigraphy.
- Secondary Outcome Measures
Name Time Method