Clinical trial NCT04192916: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
Official title: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Neoplasm
Keywords: Efficacy and safety profile
Direct oral anticoagulants
Real world data
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MPN treated with any DOAC for AF or VTE

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.


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)

Primary outcomes:
measure: Cumulative incidence of major thrombosis and bleeding
timeFrame: At 5 year from the start of treatment with DOACs
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai New York
state: New York
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre Toronto
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Verona
country: Italy
facility: Divisione Ematologia, Ospedale Borgo Roma
state: Veneto
city: Bergamo
country: Italy
facility: ASST- Papa Giovanni XXIII - S.I.M.T.
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi
city: Firenze
country: Italy
facility: AOU Careggi di Firenze
city: Monza
country: Italy
facility: ASST MONZA Ospedale San Gerardo Clinica Ematologica
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
city: Palermo
country: Italy
facility: AOU Policlinico di Palermo
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo S.C Ematologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
city: Barcellona
country: Spain
facility: Hospital Clinic, Hematology Department
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References: