Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms (MPN-DOACs)
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|ClinicalTrials.gov Identifier: NCT04192916|
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events).
While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known.
The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of:
- cardioembolic stroke in patients with MPN with AF
- recurrent thrombosis in patients with MPN with VTE
- major bleeding in all patients with MPN.
The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.
|Condition or disease||Intervention/treatment|
|Myeloproliferative Neoplasm||Drug: DOACs|
|Study Type :||Observational|
|Estimated Enrollment :||192 participants|
|Official Title:||Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||June 30, 2020|
|MPN patients treated with DOACs||
Direct Oral Anticoagulants
- Combined risk of major thrombosis and bleeding [ Time Frame: At 5 year from the start of treatment with DOACs ]
- cardioembolic strokes in MPN patients with Atrial fibrillation OR
- recurrent thrombosis in MPN patients with Venous Thromboembolism OR
- major bleeding in all MPN patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192916
|Contact: Alessandra Carobbiofirstname.lastname@example.org|