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Prevention study for Prolonged Anticoagulation
Official title Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
ClinicalTrials.gov ID: NCT05089227
What this study is testing
What is treatment "intervention"?
treatment "intervention" is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prolonged anticoagulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence \ 3 days, surgery, age \>70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient aged ≥ 18 years
- Patient with a diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) (infections, hematologic diseases, systemic diseases), according...
- Hemoglobin \<12 g/dL
- and decreased haptoglobin (\<0.4 g/L)
- and positive direct antiglobulin test (direct Coombs test) (IgG +/- C3d)
You likely can't join if
- Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic...
- Patients on curative anticoagulation (venous thromboembolic disease, atrial fibrillation)
- Patient on dual antiaggregation 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
See the full eligibility criteria
- 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)
- Patient newly diagnosed or relapse
- Patient with an estimated life expectancy of more than 6 months
- Patient who provided free, written and informed consent
- Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic angioscanner or pulmonary scintigraphy).
- Patients on curative anticoagulation (venous thromboembolic disease, atrial fibrillation)
- Patient on dual antiaggregation 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 \ 1.5, ALT elevation \>2 times the upper limit of normal)
- Patients receiving concomitant CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) or CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these therapies cannot be...
- Patients with a contraindication to enoxaparin:
- allergy to the drug
- history of heparin-induced thrombocytopenia
- Patient with cold agglutinin-related AHAI (C3d-positive ADT alone with identification of cold agglutinins)
- Patient with severe disorders of hemostasis:
- hypofibrinogenemia \< 2 g/L,
- disseminated intravascular coagulation (APTT prolongation\>1.2, and PT\ 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 measure of legal protection
- 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...
- Patient of legal age who is unable to provide consent
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.