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

Completed

• Conditions: Myeloproliferative Neoplasm
• Interventions: Drug: DOACs

• Registration Number: NCT04192916
• Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2020-03-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPN patients treated with DOACs	DOACs	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (18)

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

Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

ASST- Papa Giovanni XXIII - S.I.M.T.; 🇮🇹 Bergamo, 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

Ospedale San Bortolo di Vicenza - U.O.C di Ematologia; 🇮🇹 Vicenza, Italy

Hospital Clinic, Hematology Department; 🇪🇸 Barcellona, Spain

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom