Prolonged AnticoagulationPhase 2API-AHAINCT05089227
Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
A Phase 2 study testing treatment "intervention", treatment "standard" and biological assessment in people with Prolonged Anticoagulation and Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Anticoagulation, Venous Thromboembolic Disease, Autoimmune Hemolytic Anemia
- What is being tested?
- treatment "intervention", treatment "standard" and biological assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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 CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) or CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these therapies cannot be discontinued or modified
- 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<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 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 unable to have effective contraception (i.e., provided by an estrogen-progestin oral contraceptive or progestogen, a contraceptive implant, an intrauterine device or a tubal ligation)
- Patient of legal age who is unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Sylvain AUDIA, 03.80.29.34.32 ext. +33, sylvain.audia@chu-dijon.fr
About this study
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies.
Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 [4.7; 12.0] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest >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.
Read more
AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during "flare-ups" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients.
Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE.
In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.
- Being tested
- treatment "intervention", treatment "standard", biological assessment
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment "intervention"Drug
for a total of 12 weeks, prophylactic heparin therapy during hospitalization followed by prophylactic oral anticoagulation with apixaban
treatment "standard"Drug
during hospitalization prophylactic heparin therapy followed by management without prophylactic anticoagulation.
biological assessmentBiological
CBC, reticulocytes, haptoglobin, LDH, bilirubin
| Study group | Role | What they receive |
|---|---|---|
| "intervention" group | Experimental | Not described Receives: Drug: treatment "intervention"; Biological: biological assessment |
| "standard" group | Active comparator | Not described Receives: Drug: treatment "standard"; Biological: biological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of clinical venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE))
defined by the presence of DVT confirmed by venous Doppler and/or PE confirmed by thoracic angioscan or ventilation/perfusion lung scintigraphy.
Measured: 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start3 Feb 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged AnticoagulationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089227
- Sponsor's protocol ID
- AUDIA PHRCI 2019
- Acronym
- API-AHAI
- Status last verified
- Dec 2025
- First submitted
- 11 Oct 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- API-AHAI / AUDIA PHRCI 2019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies.
Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 [4.7; 12.0] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest >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.
AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during "flare-ups" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients.
Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE.
In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "intervention" group | Experimental | Drug: treatment "intervention", Biological: biological assessment |
| "standard" group | Active comparator | Drug: treatment "standard", Biological: biological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment "intervention"for a total of 12 weeks, prophylactic heparin therapy during hospitalization followed by prophylactic oral anticoagulation with apixaban | Drug | "intervention" group |
| treatment "standard"during hospitalization prophylactic heparin therapy followed by management without prophylactic anticoagulation. | Drug | "standard" group |
| biological assessmentCBC, reticulocytes, haptoglobin, LDH, bilirubin | Biological | "intervention" group, "standard" group |
Primary outcome
Occurrence of clinical venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE))
Time frame: 24 weeks after randomization
defined by the presence of DVT confirmed by venous Doppler and/or PE confirmed by thoracic angioscan or ventilation/perfusion lung scintigraphy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis
Embolism and Thrombosis, Anticoagulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treatment "intervention", treatment "standard" and biological assessment in people with Prolonged Anticoagulation and Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain AUDIA (03.80.29.34.32 ext. +33, sylvain.audia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of clinical venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE)) (time frame: 24 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.