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

NCT04192916 | Completed

• 1 other identifier: MPN-DOACs
• Study Type: observational
• Target: 442
• Locations: 7 countries
• Sites: 18

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.

Conditions

Myeloproliferative Neoplasm

Keywords

Efficacy and safety profile; Direct oral anticoagulants; Real world data

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MPN patients treated with DOACs

Drug: DOACs

Interventions

DOACs DRUG

Direct Oral Anticoagulants

Also known as: Dabigatran, Edoxaban, Rivaroxaban, Apixaban

MPN patients treated with DOACs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MPN treated with any DOAC for AF or VTE

You may qualify if:

• 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.

You may not qualify if:

• Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (18)

Mount Sinai New York

New York, New York, 10029, United States

Location

Princess Margaret Cancer Centre Toronto

Toronto, Canada

Location

Centre Hospitalier Universitaire de Brest

Brest, France

Location

RWTH Aachen University

Aachen, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Divisione Ematologia, Ospedale Borgo Roma

Verona, Veneto, 37134, Italy

Location

ASST- Papa Giovanni XXIII - S.I.M.T.

Bergamo, 24127, Italy

Location

Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

AOU Careggi di Firenze

Florence, Italy

Location

ASST MONZA Ospedale San Gerardo Clinica Ematologica

Monza, 20900, Italy

Location

Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

Napoli, 80131, Italy

Location

AOU Policlinico di Palermo

Palermo, Italy

Location

Fondazione IRCCS Policlinico San Matteo S.C Ematologia

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia

Roma, 00168, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia

Torino, 10126, Italy

Location

Ospedale San Bortolo di Vicenza - U.O.C di Ematologia

Vicenza, 36100, Italy

Location

Hospital Clinic, Hematology Department

Barcelona, 08034, Spain

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Dabigatran; edoxaban; Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

DE (2); US (1); IT (11); FR (1); CA (1); ES (1); GB (1)