MPN-DOACs: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

Sponsor

Fondazione per la Ricerca Ospedale Maggiore (Other)

Overall Status

Completed

CT.gov ID

NCT04192916

Collaborator

(none)

442

Enrollment

Locations

Actual Duration (Months)

24.6

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Myeloproliferative Neoplasm	Drug: DOACs

Study Design

Study Type:

Observational

Actual Enrollment :

442 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 :

Sep 1, 2019

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
MPN patients treated with DOACs	Drug: DOACs Direct Oral Anticoagulants Other Names: Dabigatran Edoxaban Rivaroxaban Apixaban

Arm

Intervention/Treatment

MPN patients treated with DOACs

Drug: DOACs

Direct Oral Anticoagulants

Other Names:

Dabigatran

Edoxaban

Rivaroxaban

Apixaban

Outcome Measures

Primary Outcome Measures

Cumulative incidence of major thrombosis and bleeding [At 5 year from the start of treatment with DOACs]
Cumulative incidence of major arterial and venous thrombosis and major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai New York	New York	New York	United States	10029
2	Princess Margaret Cancer Centre Toronto	Toronto		Canada
3	Centre Hospitalier Universitaire de Brest	Brest		France
4	RWTH Aachen University	Aachen		Germany
5	Johannes Wesling Klinikum Minden	Minden		Germany
6	Divisione Ematologia, Ospedale Borgo Roma	Verona	Veneto	Italy	37134
7	ASST- Papa Giovanni XXIII - S.I.M.T.	Bergamo		Italy	24127
8	Policlinico S. Orsola - Malpighi	Bologna		Italy
9	AOU Careggi di Firenze	Firenze		Italy
10	ASST MONZA Ospedale San Gerardo Clinica Ematologica	Monza		Italy	20900
11	Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo	Napoli		Italy	80131
12	AOU Policlinico di Palermo	Palermo		Italy
13	Fondazione IRCCS Policlinico San Matteo S.C Ematologia	Pavia		Italy	27100
14	Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia	Roma		Italy	00168
15	A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia	Torino		Italy	10126
16	Ospedale San Bortolo di Vicenza - U.O.C di Ematologia	Vicenza		Italy	36100
17	Hospital Clinic, Hematology Department	Barcellona		Spain	08034
18	Guy's and St Thomas' NHS Foundation Trust	London		United Kingdom