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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials