AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms (AVAJAK)
Primary Purpose
Polycythemia Vera, Essential Thrombocythemia, Prefibrotic/Early Primary Myelofibrosis
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Direct Oral Anticoagulants
Low-dose aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Polycythemia Vera focused on measuring Venous ThromboEmbolism, Arterial Thrombosis, Hemorrhage
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:
- based on age (> 60-year-old)
- 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.
Sites / Locations
- CHU d'AngersRecruiting
- CH d'Annecy
- CH d'Argenteuil
- CH d'AvignonRecruiting
- CH de la Côte Basque Bayonne
- CHU BordeauxRecruiting
- CHU BrestRecruiting
- CH de Béziers
- Hôpital privé Cesson-Sévigné
- CHU de Clermont-Ferrand
- Hôpital Henri Mondor (APHP)Recruiting
- CHU Grenoble AlpesRecruiting
- CHD Vendée La Roche Sur YonRecruiting
- CHU Le Havre
- CH Le Mans
- CH Libourne
- CHU de Limoges - Hôpital DupuytrenRecruiting
- Centre Léon Bérard Lyon
- CHU de Montpellier
- CH de MorlaixRecruiting
- CHU de NancyRecruiting
- CHU de Nantes - Hôtel-Dieu
- Hôpital Privé du Confluent Nantes
- CHR d'OrléansRecruiting
- Hôpital St-Louis (APHP)Recruiting
- Hôpital Cochin (APHP)
- CH de Perpignan
- CH de PérigueuxRecruiting
- CHIC de QuimperRecruiting
- CHU de Rennes
- CH de Rochefort
- CH de RoubaixRecruiting
- Centre Henri Becquerel de RouenRecruiting
- CHU La Réunion - Site Nord Félix GUYON
- CHU La Réunion - Site Sud
- Institut de Cancérologie Lucien Neuwirth St-Priest-en-JarezRecruiting
- Clinique Sainte Anne Strasbourg
- CHU de ToursRecruiting
- CH Bretagne Atlantique VannesRecruiting
- CH de Versailles
- CH Paul-Brousse (APHP)
- Médipôle Hôpital Mutualiste VilleurbanneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
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
Patients randomized to receive Low-Dose Aspirin Aspirin 100 mg one per day
Outcomes
Primary Outcome Measures
Time to occurrence of arterial or venous thromboembolic events.
Nb and type of thrombotic events during the FU
Secondary Outcome Measures
Time to occurrence of major and clinically relevant non-major bleedings as defined by International Society on Thrombosis and Haemostasis
Nb and type of new hemorrhagic events
Time to occurrence of arterial thromboembolic events.
Nb and type of new arterial events
Time to occurrence of venous thromboembolic
Nb and type of new venous events
Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs
Nb and type of new thromboembolic and hemorrhage events
Time to occurrence of serious adverse events others than thromboses and hemorrhages hemorrhages
Nb, type and grade of adverse events observed
Overall survival and event-free survival
Time to last news and time to first event
Therapeutic adherence
Therapeutic adherence by Girerd auto-questionnaire
Occurrence of atrial fibrillation episode (time to occurrence).
Nb and timing of atrial fibrillation event
Evaluation of Quality of life under antithrombotic drugs
Evaluation of QoL by the use of MPN-SAF Quality of life
Evaluation of costs and incremental cost utility ratio of low-dose DOAC compared to low-dose aspirin
Evaluation of benefits/costs under antithrombotic drugs
Evaluation of Quality of life under antithrombotic drugs
Evaluation of QoL by the use of EQ-5D-5L Quality of life
Full Information
NCT ID
NCT05198960
First Posted
November 9, 2021
Last Updated
October 20, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT05198960
Brief Title
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
Acronym
AVAJAK
Official Title
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
July 13, 2027 (Anticipated)
Study Completion Date
July 13, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases.
These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status.
In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events.
Despite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year.
All these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events.
At the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma).
In cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients.
In the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the "general cancer population" to MPN patients.
Unfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data.
We were the first to publish a "real-life" study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit/risk balance compared to patients treated with LDA without difference.
With the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycythemia Vera, Essential Thrombocythemia, Prefibrotic/Early Primary Myelofibrosis, JAK2 V617F, High-risk Patients
Keywords
Venous ThromboEmbolism, Arterial Thrombosis, Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
AVAJAK is an academic multicenter phase 3 prospective, randomized, and open label trial.
> Randomization of the patients: Patients corresponding to inclusion criteria will be randomized based on a 1:1 distribution.
Experimental group (Patients allocated to receive low-dose DOAC, at the choice of the investigator)
Apixaban 2.5 mg BID or
Rivaroxaban 10 mg OD, at the choice of the investigator.
Control group (Patients allocated to receive LDA)
- Aspirin 100 mg OD Dispensation of treatments every 6 months for 24 months
Stratification:
First stratification will be done by center
Second stratification will be done by pathology (PV/ET/ PreMF)
No stratification will be made based on DOAC drugs.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients randomized to receive Low-Dose Aspirin Aspirin 100 mg one per day
Intervention Type
Drug
Intervention Name(s)
Direct Oral Anticoagulants
Intervention Description
Patients randomized to receive DOAC, at the choice of the investigator: Apixaban 2.5 mg both in day or Rivaroxaban 10 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Low-dose aspirin
Intervention Description
Patients allocated to receive LDA: Aspirin 100 mg OD once daily.
Primary Outcome Measure Information:
Title
Time to occurrence of arterial or venous thromboembolic events.
Description
Nb and type of thrombotic events during the FU
Time Frame
Time to occurrence up to 24 months of patient follow-up
Secondary Outcome Measure Information:
Title
Time to occurrence of major and clinically relevant non-major bleedings as defined by International Society on Thrombosis and Haemostasis
Description
Nb and type of new hemorrhagic events
Time Frame
Time to occurrence up to 24 months of patient follow-up
Title
Time to occurrence of arterial thromboembolic events.
Description
Nb and type of new arterial events
Time Frame
Time to occurrence up to 24 months of patient follow-up
Title
Time to occurrence of venous thromboembolic
Description
Nb and type of new venous events
Time Frame
Time to occurrence up to 24 months of patient follow-up
Title
Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs
Description
Nb and type of new thromboembolic and hemorrhage events
Time Frame
Time to occurrence up to 24 months of patient follow-up
Title
Time to occurrence of serious adverse events others than thromboses and hemorrhages hemorrhages
Description
Nb, type and grade of adverse events observed
Time Frame
Time to occurrence up to 24 months of patient follow-up
Title
Overall survival and event-free survival
Description
Time to last news and time to first event
Time Frame
24 months
Title
Therapeutic adherence
Description
Therapeutic adherence by Girerd auto-questionnaire
Time Frame
24 months
Title
Occurrence of atrial fibrillation episode (time to occurrence).
Description
Nb and timing of atrial fibrillation event
Time Frame
24 months
Title
Evaluation of Quality of life under antithrombotic drugs
Description
Evaluation of QoL by the use of MPN-SAF Quality of life
Time Frame
24 months
Title
Evaluation of costs and incremental cost utility ratio of low-dose DOAC compared to low-dose aspirin
Description
Evaluation of benefits/costs under antithrombotic drugs
Time Frame
24 months
Title
Evaluation of Quality of life under antithrombotic drugs
Description
Evaluation of QoL by the use of EQ-5D-5L Quality of life
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
based on age (> 60-year-old)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe IANOTTO, Pr
Phone
+33298223421
Email
jean-christophe.ianotto@chu-brest.fr
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corentin ORVAIN, PH
Phone
+33615270461
Email
corentin.orvain@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Corentin ORVAIN, PH
Facility Name
CH d'Annecy
City
Annecy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha MAUZ, PH
Phone
+33450636431
Email
nmauz@ch-annecygenevois.fr
First Name & Middle Initial & Last Name & Degree
Natacha MAUZ, PH
Facility Name
CH d'Argenteuil
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa ANDREOLI, PH
Email
annalisa.andreoli@ch-argenteuil.fr
First Name & Middle Initial & Last Name & Degree
Annalisa ANDREOLI, PH
Facility Name
CH d'Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borhane SLAMA, PH
Email
bslama@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Borhane SLAMA, PH
Facility Name
CH de la Côte Basque Bayonne
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric BAUDUER, PH
Email
frederic.bauduer@u-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Frédéric BAUDUER, PH
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axelle LASCAUX, PH
Email
axelle.lascaux@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Axelle LASCAUX, PH
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Ianotto, PUPH
Email
jean-christophe.ianotto@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Ianotto, PUPH
Facility Name
CH de Béziers
City
Béziers
ZIP/Postal Code
34500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Radwan SAAD, PH
Email
alain.saad@ch-beziers.fr
First Name & Middle Initial & Last Name & Degree
Alain Radwan SAAD, PH
Facility Name
Hôpital privé Cesson-Sévigné
City
Cesson-Sévigné
ZIP/Postal Code
35510
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît BAREAU, PH
Email
benoit.bareau@gmail.com
First Name & Middle Initial & Last Name & Degree
Benoît BAREAU, PH
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît DE RENZIS, PH
Email
bderenzis@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Benoît DE RENZIS, PH
Facility Name
Hôpital Henri Mondor (APHP)
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia ROY, PH
Email
lydia.roy@aphp.fr
First Name & Middle Initial & Last Name & Degree
Lydia ROY, PH
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu MEUNIER, PH
Email
mmeunier2@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Mathieu MEUNIER, PH
Facility Name
CHD Vendée La Roche Sur Yon
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno VILLEMAGNE, PH
Email
bruno.villemagne@chd-vendee.fr
First Name & Middle Initial & Last Name & Degree
Bruno VILLEMAGNE, PH
Facility Name
CHU Le Havre
City
Le Havre
ZIP/Postal Code
76083
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre LEBRETON, PH
Email
pierre.lebreton@ch-havre.fr
First Name & Middle Initial & Last Name & Degree
Pierre LEBRETON, PH
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI, PH
Email
klaribi@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI, PH
Facility Name
CH Libourne
City
Libourne
ZIP/Postal Code
33500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane LARA, PH
Email
Diane.Lara@ch-libourne.fr
First Name & Middle Initial & Last Name & Degree
Diane LARA, PH
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane GIRAULT, PH
Email
stephane.girault@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Stéphane GIRAULT, PH
Facility Name
Centre Léon Bérard Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck-Emmanuel NICOLINI, PH
Email
franc-emmanuel.nicolini@lyon-unicancer.fr
First Name & Middle Initial & Last Name & Degree
Franck-Emmanuel NICOLINI, PH
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franciane PAUL, PH
Email
f-paul@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Franciane PAUL, PH
Facility Name
CH de Morlaix
City
Morlaix
ZIP/Postal Code
29600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed MALOU, PH
Email
MMalou@ch-morlaix.fr
First Name & Middle Initial & Last Name & Degree
Mohamed MALOU, PH
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana RANTA, PH
Email
d.ranta@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Dana RANTA, PH
Facility Name
CHU de Nantes - Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane DUBRUILLE, PH
Email
viviane.dubruille@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Viviane DUBRUILLE, PH
Facility Name
Hôpital Privé du Confluent Nantes
City
Nantes
ZIP/Postal Code
44202
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katell LE DU, PH
Email
dr.ledu@groupeconfluent.fr
First Name & Middle Initial & Last Name & Degree
Katell LE DU, PH
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène OCHMANN, PH
Email
marlene.ochmann@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Marlène OCHMANN, PH
Facility Name
Hôpital St-Louis (APHP)
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques KILADJIAN, PUPH
Email
jean-jacques.kiladjian@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Jacques KILADJIAN, PUPH
Facility Name
Hôpital Cochin (APHP)
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela FONTENAY, PH
Email
michaela.fontenay@aphp.fr
First Name & Middle Initial & Last Name & Degree
Michaela FONTENAY, PH
Facility Name
CH de Perpignan
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne VACHERET, PH
Email
fabienne.vacheret@ch-perpignan.fr
First Name & Middle Initial & Last Name & Degree
Fabienne VACHERET, PH
Facility Name
CH de Périgueux
City
Périgueux
ZIP/Postal Code
24019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire CALMETTE, PH
Email
claire.calmettes@ch-perigueux.fr
First Name & Middle Initial & Last Name & Degree
Claire CALMETTE, PH
Facility Name
CHIC de Quimper
City
Quimper
ZIP/Postal Code
29107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lénaïg LE CLECH, PH
Email
l.leclech@ch-cornouaille.fr
First Name & Middle Initial & Last Name & Degree
Lénaïg LE CLECH, PH
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BERNARD, PH
Email
marc.nernard@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Marc BERNARD, PH
Facility Name
CH de Rochefort
City
Rochefort
ZIP/Postal Code
17300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume DENIS, PH
Email
guillaume.denis@ch-rochefort.fr
First Name & Middle Initial & Last Name & Degree
Guillaume DENIS, PH
Facility Name
CH de Roubaix
City
Roubaix
ZIP/Postal Code
59100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu WEMEAU, PH
Email
mathieu.wemeau@chu-roubaix.fr
First Name & Middle Initial & Last Name & Degree
Mathieu WEMEAU, PH
Facility Name
Centre Henri Becquerel de Rouen
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JARDIN Fabrice, PH
Email
fabrice.jardin@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Fabrice JARDIN, PH
Facility Name
CHU La Réunion - Site Nord Félix GUYON
City
Saint-Denis
ZIP/Postal Code
97405
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane VANDERBECKEN, PH
Email
stephane.vanderbecken@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Stéphane VANDERBECKEN
Facility Name
CHU La Réunion - Site Sud
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaëlle DINE, PH
Email
raphaelle.dine@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Raphaëlle DINE, PH
Facility Name
Institut de Cancérologie Lucien Neuwirth St-Priest-en-Jarez
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie CHALAYER, PH
Email
emilie.chalayer@icloire.fr
First Name & Middle Initial & Last Name & Degree
Emilie CHALAYER, PH
Facility Name
Clinique Sainte Anne Strasbourg
City
Strasbourg
ZIP/Postal Code
92210
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anaïse BLOUET, PH
Email
ablouet@solcrr.org
First Name & Middle Initial & Last Name & Degree
Anaïse BLOUET, PH
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine MACHET, PH
Email
a.machet@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Antoine MACHET, PH
Facility Name
CH Bretagne Atlantique Vannes
City
Vannes
ZIP/Postal Code
56017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie MERCIER, PH
Email
melanie.mercier@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Mélanie MERCIER, PH
Facility Name
CH de Versailles
City
Versailles
ZIP/Postal Code
78150
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette LAMBERT, PH
Email
jlambert@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Juliette LAMBERT, PH
Facility Name
CH Paul-Brousse (APHP)
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence LE GROS, PH
Email
laurence.legros@aphp.fr
First Name & Middle Initial & Last Name & Degree
Laurence LE GROS, PH
Facility Name
Médipôle Hôpital Mutualiste Villeurbanne
City
Villeurbanne
ZIP/Postal Code
69616
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias BREHON, PH
Email
m.brehon@resamut.fr
First Name & Middle Initial & Last Name & Degree
Mathias BREHON, PH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Learn more about this trial
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
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