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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
Sponsor:
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
MPN patients treated with DOACs Drug: DOACs
Direct Oral Anticoagulants
Other Names:
  • Dabigatran
  • Edoxaban
  • Rivaroxaban
  • Apixaban




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with MPN treated with any DOAC for AF or VTE
Criteria

Inclusion Criteria:

  • diagnosis of Philadelphia-negative MPN according to World Health Organization (WHO) 2008 and/or 2016 criteria until 31/12/2018;
  • diagnosis of atrial fibrillation (AF) and/or diagnosis of venous thromboembolism (VTE) including thrombosis of deep veins of the limbs and the abdomen, cerebral and splanchnic veins (hepatic, portal, mesenteric, and splenic veins) and pulmonary embolism;
  • treatment with DOACs.

Exclusion Criteria:

• Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)


Information from the National Library of Medicine

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


Contacts
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Contact: Alessandra Carobbio +390352675136 acarobbio@fondazionefrom.it

Locations
Show Show 18 study locations
Sponsors and Collaborators
Fondazione per la Ricerca Ospedale Maggiore
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Responsible Party: Fondazione per la Ricerca Ospedale Maggiore
ClinicalTrials.gov Identifier: NCT04192916    
Other Study ID Numbers: MPN-DOACs
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione per la Ricerca Ospedale Maggiore:
Efficacy and safety profile
Direct oral anticoagulants
Real world data
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants