2024-515362-13-00RecruitingPhase 2/3
Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1008 (estimated)
- First submitted
- 4 Jul 2024
- Start date
- 1 Aug 2024
- Lead sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Diseases
- Myeloproliferative neoplasms
- EU CT number
- 2024-515362-13-00
- EudraCT number
- 2020-004652-15
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1008
- 44 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Formal indication of treatment with LDA or DOAC (thus precluding randomization)
- Concomitant use of a strong inhibitor or inducer of CYP3A4 (like Ruxolitinib)
Other illness
- Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding
- Chronic liver disease or chronic hepatitis
- Patient considered at high-risk of bleeding: patients with current or recent major or clinically relevant non major bleeding gastrointestinal or cerebral bleedings
Lab values
- Renal insufficiency with creatinine <30 ml/mn on Cockcroft and Gault Formula
Age
- No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman
Other
- PS>2 or life expectancy <12 months
- Inability to give informed consent
- Patients under curatorship/guardianship
- Planned pregnancy within 24 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier Victor Dupouy | Argenteuil Cedex | France | Recruiting |
| Centre Hospitalier d'Avignon | Avignon | France | Recruiting |
| Centre Hospitalier de la Cote Basque | Bayonne | France | Recruiting |
| Centre Hospitalier de Béziers | Béziers | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Recruiting |
| Hopital Prive Sevigne | Cesson Sevigne | France | Recruiting |
| CHU d'Estaing | Clermont-Ferrand | France | Recruiting |
| Hôpital Henri Mondor, 1 rue Gustave Eiffel, | Créteil | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Recruiting |
| Centre Hospitalier Departemental Vendee | La Roche Sur Yon Cedex 9 | France | Recruiting |
| Centre Hospitalier De Versailles | Le Chesnay Rocquencourt | France | Recruiting |
| Groupe Hospitalier Du Havre | Le Havre Cedex | France | Recruiting |
| Centre Hospitalier Le Mans | Le Mans Cedex 9 | France | Recruiting |
| Centre Hospitalier De Libourne Robert Boulin | Libourne | France | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges | Limoges Cedex 1 | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille Cedex 05 | France | Recruiting |
| Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources | Mont-De-Marsan Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier des Pays de Morlaix | Morlaix | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Hôpital Privé du Confluent | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire d'Orléans | ORLEANS | France | Recruiting |
| Hopital Saint Louis | Paris | France | Recruiting |
| Hopital Cochin Saint Vincent De Paul | Paris | France | Recruiting |
| Centre Hospitalier de Perigueux | Périgueux | France | Recruiting |
| Centre Hospitalier De Perpignan | Perpignan Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Centre Hospitalier Annecy Genevois | Pringy Cedex | France | Recruiting |
| Centre Hospitalier Intercommunal De Cornouaille | Quimper Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Recruiting |
| Centre Hospitalier De Rochefort | Rochefort Cedex | France | Recruiting |
| Centre hospitalier de Roubaix | Roubaix | France | Recruiting |
| Centre Henri Becquerel | Rouen Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De La Reunion | Saint-Denis | France | Recruiting |
| Centre Hospitalier Universitaire de la Réunion - Site Sud | Saint-Pierre Cedex | France | Recruiting |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | France | Recruiting |
| Clinique Sainte Anne | Strasbourg | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Recruiting |
| CHU Nancy - Hôpital Brabois | Vandoeuvre lès Nancy | France | Recruiting |
| Centre Hospitalier Bretagne Atlantique | Vannes | France | Recruiting |
| Hopital Paul Brousse | Villejuif Cedex | France | Recruiting |
| Médipôle Hôpital Mutualiste Villeurbanne | Villeurbanne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.