AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
NCT ID: NCT05198960
Last Updated: 2025-02-04
Study Results
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Basic Information
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RECRUITING
PHASE3
1308 participants
INTERVENTIONAL
2022-07-13
2027-07-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
\> 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.
PREVENTION
NONE
Study Groups
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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
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.
Control group
Patients randomized to receive Low-Dose Aspirin Aspirin 100 mg one per day
Low-dose aspirin
Patients allocated to receive LDA: Aspirin 100 mg OD once daily.
Interventions
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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.
Low-dose aspirin
Patients allocated to receive LDA: Aspirin 100 mg OD once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHU d'Angers
Angers, , France
CH d'Annecy
Annecy, , France
CH d'Argenteuil
Argenteuil, , France
CH d'Avignon
Avignon, , France
CH de la Côte Basque Bayonne
Bayonne, , France
CH de Béziers
Béziers, , France
CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
Hôpital privé Cesson-Sévigné
Cesson-Sévigné, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Henri Mondor (APHP)
Créteil, , France
CHU Grenoble Alpes
Grenoble, , France
CHD Vendée La Roche Sur Yon
La Roche-sur-Yon, , France
CHU Le Havre
Le Havre, , France
CH Le Mans
Le Mans, , France
CH Libourne
Libourne, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
Centre Léon Bérard Lyon
Lyon, , France
CHU de Montpellier
Montpellier, , France
CH de Morlaix
Morlaix, , France
CHU de Nancy
Nancy, , France
CHU de Nantes - Hôtel-Dieu
Nantes, , France
Hôpital Privé du Confluent Nantes
Nantes, , France
CHR d'Orléans
Orléans, , France
Hôpital St-Louis (APHP)
Paris, , France
Hôpital Cochin (APHP)
Paris, , France
CH de Perpignan
Perpignan, , France
CH de Périgueux
Périgueux, , France
CHIC de Quimper
Quimper, , France
CHU de Rennes
Rennes, , France
CH de Rochefort
Rochefort, , France
CH de Roubaix
Roubaix, , France
Centre Henri Becquerel de Rouen
Rouen, , France
CHU La Réunion - Site Nord Félix GUYON
Saint-Denis, , France
CHU La Réunion - Site Sud
Saint-Pierre, , France
Institut de Cancérologie Lucien Neuwirth St-Priest-en-Jarez
Saint-Priest-en-Jarez, , France
Clinique Sainte Anne Strasbourg
Strasbourg, , France
CHU de Tours
Tours, , France
CH Bretagne Atlantique Vannes
Vannes, , France
CH de Versailles
Versailles, , France
CH Paul-Brousse (APHP)
Villejuif, , France
Médipôle Hôpital Mutualiste Villeurbanne
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC20.0263 (AVAJAK)
Identifier Type: -
Identifier Source: org_study_id
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