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

Launched by UNIVERSITY HOSPITAL, BREST · Jan 5, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Venous Thrombo Embolism Arterial Thrombosis Hemorrhage

ClinConnect Summary

The AVAJAK trial is studying whether two blood-thinning medications, apixaban and rivaroxaban, are more effective than low-dose aspirin in preventing blood clots in patients with specific blood disorders known as myeloproliferative neoplasms (MPNs), particularly those with a mutation called JAK2V617F. These disorders, which include conditions like Polycythemia Vera and Essential Thrombocythemia, can increase the risk of serious blood clots, and current treatments may not fully prevent these complications. This trial aims to determine if the newer medications can provide better protection against these risks.

To participate, patients must have a diagnosis of one of the specified MPNs and carry the JAK2V617F mutation. They should also be considered "high-risk," which generally includes individuals over 60 years old or those with a history of blood clots. Participants will be closely monitored throughout the study to evaluate the effectiveness and safety of the medications. It’s important to note that certain individuals with a high risk of bleeding or specific medical conditions may not be eligible for the trial. Overall, this study hopes to improve treatment options for patients with these serious blood disorders.

Gender

ALL

Eligibility 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.

About University Hospital, Brest

The University Hospital of Brest is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. With a strong emphasis on interdisciplinary collaboration, the hospital serves as a hub for cutting-edge clinical trials aimed at improving treatment outcomes across various medical specialties. Leveraging its robust academic affiliations and state-of-the-art facilities, the University Hospital of Brest is committed to fostering scientific discovery and enhancing the quality of life for patients through evidence-based practices and pioneering research initiatives.

Locations

Tours, , France

Montpellier, , France

Brest, , France

Avignon, , France

Nancy, , France

Clermont Ferrand, , France

Rennes, , France

Angers, , France

Le Mans, , France

Limoges, , France

Périgueux, , France

Nantes, , France

Argenteuil, , France

Roubaix, , France

Bordeaux, , France

Saint Cloud, , France

Grenoble, , France

Le Havre, , France

Libourne, , France

Annecy, , France

Bayonne, , France

Béziers, , France

Cesson Sévigné, , France

Créteil, , France

La Roche Sur Yon, , France

Lyon, , France

Morlaix, , France

Orléans, , France

Paris, , France

Paris, , France

Perpignan, , France

Quimper, , France

Rochefort, , France

Rouen, , France

Saint Priest En Jarez, , France

Vannes, , France

Versailles, , France

Villejuif, , France

Villeurbanne, , France

Nantes, , France

Saint Denis, , France

Saint Pierre, , France

Strasbourg, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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