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Compares treatment options for Polycythemia Vera
Official title AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT05198960
What this study is testing
What is Direct Oral Anticoagulants?
Direct Oral Anticoagulants is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycythemia vera.
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
- Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells.
- Phase 3: a large, late-stage study
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
- Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory).
- Patients with JAK2V617F mutation (threshold allele burden \> 1%).
- Patients considered as "high-risk" patients:
- based on age (\> 60-year-old)
- based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old.
You likely can't join if
- Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding.
- Formal indication of treatment with aspirin or DOAC (thus precluding randomization).
- Inability to give informed consent.
- Patients under curatorship/guardianship
- Concomitant use of a strong inhibitor or inducer of CYP3A4 (like ruxolitinib).
- Chronic liver disease or chronic hepatitis.
See the full eligibility criteria
- Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory).
- Patients with JAK2V617F mutation (threshold allele burden \> 1%).
- Patients considered as "high-risk" patients:
- based on age (\> 60-year-old)
- based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old.
- Length of time from MPN diagnostic to inclusion will not exceed 12 months.
- Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding.
- Formal indication of treatment with aspirin or DOAC (thus precluding randomization).
- Inability to give informed consent.
- Patients under curatorship/guardianship
- Concomitant use of a strong inhibitor or inducer of CYP3A4 (like ruxolitinib).
- Chronic liver disease or chronic hepatitis.
- Renal insufficiency with creatinine \<30 ml/mn on Cockcroft and Gault Formula
- Patient considered at high-risk of bleeding: patients with current or recent major or clinical relevant non major bleeding gastrointestinal or cerebral bleedings
- Planned pregnancy within 24 months
- No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman
- PS\>2 or life expectancy \<12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Annecy, France
- Argenteuil, France
- Avignon, France
- Bayonne, France
- Béziers, France
- Bordeaux, France
- Brest, France
- Cesson-Sévigné, France
- Clermont-Ferrand, France
- Créteil, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Havre, France
- Le Mans, France
- Libourne, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Morlaix, France
+ 20 more site(s).
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 Angers, France; Annecy, France; Argenteuil, France; Avignon, France; Bayonne, France; Béziers, France and 34 more location(s). 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.