Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
NCT ID: NCT04192916
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
442 participants
OBSERVATIONAL
2019-09-01
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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MPN patients treated with DOACs
DOACs
Direct Oral Anticoagulants
Interventions
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DOACs
Direct Oral Anticoagulants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
OTHER
Responsible Party
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Locations
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Mount Sinai New York
New York, New York, United States
Princess Margaret Cancer Centre Toronto
Toronto, , Canada
Centre Hospitalier Universitaire de Brest
Brest, , France
RWTH Aachen University
Aachen, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Divisione Ematologia, Ospedale Borgo Roma
Verona, Veneto, Italy
ASST- Papa Giovanni XXIII - S.I.M.T.
Bergamo, , Italy
Policlinico S. Orsola - Malpighi
Bologna, , Italy
AOU Careggi di Firenze
Florence, , Italy
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, , Italy
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Napoli, , Italy
AOU Policlinico di Palermo
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo S.C Ematologia
Pavia, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
Roma, , Italy
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
Torino, , Italy
Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
Vicenza, , Italy
Hospital Clinic, Hematology Department
Barcelona, , Spain
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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MPN-DOACs
Identifier Type: -
Identifier Source: org_study_id
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