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

Myeloproliferative Neoplasm Clinical Trial

— MPN-DOACs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192916
• Other study ID #: MPN-DOACs
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: December 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms

Intervention

Drug:
• DOACs
Direct Oral Anticoagulants

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre Toronto	Toronto
France	Centre Hospitalier Universitaire de Brest	Brest
Germany	RWTH Aachen University	Aachen
Germany	Johannes Wesling Klinikum Minden	Minden
Italy	ASST- Papa Giovanni XXIII - S.I.M.T.	Bergamo
Italy	Policlinico S. Orsola - Malpighi	Bologna
Italy	AOU Careggi di Firenze	Firenze
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	Divisione Ematologia, Ospedale Borgo Roma	Verona	Veneto
Italy	Ospedale San Bortolo di Vicenza - U.O.C di Ematologia	Vicenza
Spain	Hospital Clinic, Hematology Department	Barcellona
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United States	Mount Sinai New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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