Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms

Phase 2/3

Not yet recruiting

Conditions: Philadelphia-negative myeloproliferative neoplasms are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF).

Registration Number: 2024-515362-13-00

Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 1008

Inclusion Criteria

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

Exclusion Criteria

Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding

No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman

PS>2 or life expectancy <12 months

Formal indication of treatment with LDA 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 clinically relevant non major bleeding gastrointestinal or cerebral bleedings

Planned pregnancy within 24 months

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to occurrence of arterial or venous thromboembolic events		Time to occurrence of arterial or venous thromboembolic events

Secondary Outcome Measures

Name	Time	Method
Time to occurrence of major and clinically relevant non-major bleedings as defined by ISTH		Time to occurrence of major and clinically relevant non-major bleedings as defined by ISTH
Time to occurrence of arterial thromboembolic events		Time to occurrence of arterial thromboembolic events
Time to occurrence of venous thromboembolic events		Time to occurrence of venous thromboembolic events
Time to occurrence of thromboembolic and bleeding events according to PV or ET or PreMF status		Time to occurrence of thromboembolic and bleeding events according to PV or ET or PreMF status
Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs		Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs
Time to occurrence of serious adverse events others than thromboses and hemorrhages		Time to occurrence of serious adverse events others than thromboses and hemorrhages
Occurrence of atrial fibrillation episodes (time to occurrence)		Occurrence of atrial fibrillation episodes (time to occurrence)
Overall survival and event free survival (events defined above) at 24 months		Overall survival and event free survival (events defined above) at 24 months
Adjudicated mortality (non-cardiovascular and cardiovascular), time to occurence		Adjudicated mortality (non-cardiovascular and cardiovascular), time to occurence
Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months		Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months
Quality of life will be studied (EQ-5D-5L and MPN-SAF-TSS auto-questionnaire) during the study treatment period of 24 months		Quality of life will be studied (EQ-5D-5L and MPN-SAF-TSS auto-questionnaire) during the study treatment period of 24 months
Evaluation of costs and incremental cost utility ratio (cost per QALY) of low-dose DOAC compared to LDA		Evaluation of costs and incremental cost utility ratio (cost per QALY) of low-dose DOAC compared to LDA

Trial Locations

Locations (42): CHU d'Estaing
🇫🇷
Clermont-Ferrand, France
Centre Hospitalier Intercommunal De Cornouaille
🇫🇷
Quimper Cedex, France
Centre Hospitalier Universitaire De Nantes
🇫🇷
Nantes, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
Centre Hospitalier Universitaire d’Orléans
🇫🇷
Orléans, France
Centre Hospitalier Universitaire de la Réunion - Site Sud
🇫🇷
Saint-Pierre Cedex, France
Centre Hospitalier De Perpignan
🇫🇷
Perpignan Cedex, France
Centre Hospitalier De Rochefort
🇫🇷
Rochefort Cedex, France
Hopital Saint Louis
🇫🇷
Paris, France
Centre Hospitalier De La Cote Basque
🇫🇷
Bayonne, France
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CHU d'Estaing
🇫🇷Clermont-Ferrand, France
Benoît DE RENZIS
Site contact
0473750065
bderenzis@chu-clermontferrand.fr