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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPN patients treated with DOACs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOACs | Drug | Direct Oral Anticoagulants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of major thrombosis and bleeding | Cumulative incidence of major arterial and venous thrombosis and major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) | At 5 year from the start of treatment with DOACs |
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Inclusion Criteria:
Exclusion Criteria:
• Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)
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Patients with MPN treated with any DOAC for AF or VTE
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai New York | New York | New York | 10029 | United States | ||
| Princess Margaret Cancer Centre Toronto |
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| 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 | 37134 | Italy |
| ASST- Papa Giovanni XXIII - S.I.M.T. | Bergamo | 24127 | Italy |
| Policlinico S. Orsola - Malpighi | Bologna | Italy |
| AOU Careggi di Firenze | Florence | Italy |
| ASST MONZA Ospedale San Gerardo Clinica Ematologica | Monza | 20900 | Italy |
| Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo | Naples | 80131 | Italy |
| AOU Policlinico di Palermo | Palermo | Italy |
| Fondazione IRCCS Policlinico San Matteo S.C Ematologia | Pavia | 27100 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia | Roma | 00168 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia | Torino | 10126 | Italy |
| Ospedale San Bortolo di Vicenza - U.O.C di Ematologia | Vicenza | 36100 | Italy |
| Hospital Clinic, Hematology Department | Barcelona | 08034 | Spain |
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C552171 | edoxaban |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
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