Comparing Apixaban and Rivaroxaban to Aspirin for Preventing Blood Clots in Certain Blood Disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of direct oral anticoagulants, specifically Apixaban and Rivaroxaban, compared to low-dose aspirin for the primary prevention of thrombo-embolic complications in patients with JAK2V617F-positive myeloproliferative neoplasms. The study focuses on patients diagnosed with Polycythemia Vera, Essential Thrombocythemia, or Prefibrotic Myelofibrosis who are considered high-risk due to age or thrombotic history. Participants will be randomly assigned to receive either the anticoagulants or aspirin, with the aim of determining which treatment better reduces the risk of blood clots. The trial is designed to provide insights into optimal management strategies for these high-risk patients.

Why it matters

Who can join: the full rules

Inclusion 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:

  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.

Exclusion Criteria:

* 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.

Where it's running

• CHU d'Angers
  Angers, France Recruiting
• CH d'Avignon
  Avignon, France Recruiting
• CHU Bordeaux
  Bordeaux, France Recruiting
• CHU Brest
  Brest, France Recruiting
• Hôpital Henri Mondor (APHP)
  Créteil, France Recruiting
• CHU Grenoble Alpes
  Grenoble, France Recruiting

Study contacts

• Study coordinator: Jean-Christophe IANOTTO, Pr
• Email: jean-christophe.ianotto@chu-brest.fr
• Phone: +33298223421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.