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

AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms

Phase 3 Interventional University Hospital, Brest · NCT05198960

This study is testing whether the blood thinners Apixaban and Rivaroxaban can prevent blood clots better than low-dose aspirin in patients with certain blood disorders who are at high risk.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1308 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Brest Academic / other
Drugs / interventionsruxolitinib
Locations42 sites (Angers and 41 other locations)
Trial IDNCT05198960 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 and older with a diagnosis of Polycythemia Vera, Essential Thrombocythemia, or Prefibrotic Myelofibrosis who have the JAK2V617F mutation and are considered high-risk.

Not a fit: Patients who have contraindications to aspirin or direct oral anticoagulants, or those already receiving these treatments, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prevention of thrombo-embolic complications in patients with specific blood disorders.

How similar studies have performed: Other studies have explored anticoagulant therapies in similar patient populations, but this specific comparison of Apixaban and Rivaroxaban against aspirin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Angers and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Polycythemia VeraEssential ThrombocythemiaPrefibrotic/Early Primary MyelofibrosisJAK2 V617FHigh-risk PatientsVenous ThromboEmbolismArterial ThrombosisHemorrhage
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.