Authorised Therapeutic exploratory (Phase II) autoimmune hemolytic anemia

API-AHAI - Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study

EU CTIS ID: 2024-513191-17-00

What this study is testing

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.

Therapeutic exploratory (Phase II)

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

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

You likely can't join if

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

See the full eligibility criteria

Who can join

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

What rules you out

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.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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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.