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Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms
EU CTIS ID: 2024-515362-13-00
What this study is testing
To demonstrate that low-dose DOAC is more effective than LDA in the primary prevention of arterial or venous thrombosis in JAK2V617F-positive high-risk MPN patients
- Phase II and Phase III (Integrated)
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
- Patients with diagnosis of Polycythemia Vera or Essential Thrombocythemia or Prefibrotic myelofibrosis 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: - 1°) based on age (> 60-year-old) - 2°) 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
You likely can't join if
- Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding
- No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman
- PS>2 or life expectancy <12 months
- Formal indication of treatment with LDA or DOAC (thus precluding randomization)
- Inability to give informed consent
- Patients under curatorship/guardianship
See the full eligibility criteria
- Patients with diagnosis of Polycythemia Vera or Essential Thrombocythemia or Prefibrotic myelofibrosis 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: - 1°) based on age (> 60-year-old) - 2°) 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
- No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman
- PS>2 or life expectancy <12 months
- Formal indication of treatment with LDA 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 clinically relevant non major bleeding gastrointestinal or cerebral bleedings
- Planned pregnancy within 24 months
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.