Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - Length of time from MPN diagnostic to inclusion will not exceed 12 months.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Brest|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Polycythemia Vera, Essential Thrombocythemia, Prefibrotic/Early Primary Myelofibrosis, JAK2 V617F, High-risk Patients|
Experimental: Experimental group
Patients randomized to receive Direct Oral Anticoagulants, at the choice of the investigator Apixaban 2.5 mg both in day or Rivaroxaban 10 mg one per day, at the choice of the investigator
Active Comparator: Control group
Patients randomized to receive Low-Dose Aspirin Aspirin 100 mg one per day
Drug: - Direct Oral Anticoagulants
Patients randomized to receive DOAC, at the choice of the investigator: Apixaban 2.5 mg both in day or Rivaroxaban 10 mg once daily.
Drug: - Low-dose aspirin
Patients allocated to receive LDA: Aspirin 100 mg OD once daily.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.