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.
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.
Brief Title
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
Categories
Completion Date
Completion Date Type
Actual
Conditions
Myeloproliferative Neoplasm
Eligibility 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)
* 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)
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Efficacy and safety profile
Direct oral anticoagulants
Real world data
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04192916
Org Class
Other
Org Full Name
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Org Study Id
MPN-DOACs
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
Primary Outcomes
Outcome Description
Cumulative incidence of major arterial and venous thrombosis and major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)
Outcome Measure
Cumulative incidence of major thrombosis and bleeding
Outcome Time Frame
At 5 year from the start of treatment with DOACs
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients with MPN treated with any DOAC for AF or VTE
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Swati Goel
Investigator Email
swgoel@montefiore.org
Investigator Phone
718-920-6310 / 718-920-4137