Myeloproliferative NeoplasmMPN-DOACsNCT04192916
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
An observational study of Myeloproliferative Neoplasm, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 18 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- DOACs
- Type of treatment
- Pill or oral medicine
- How many people
- 442 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MPN treated with any DOAC for AF or VTE
Who may be able to join
- 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.
Who cannot join
- Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Italy11 sites
ASST- Papa Giovanni XXIII - S.I.M.T.
Bergamo, 24127
Policlinico S. Orsola - Malpighi
Bologna
AOU Careggi di Firenze
Florence
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, 20900
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, 80131
AOU Policlinico di Palermo
Palermo
Fondazione IRCCS Policlinico San Matteo S.C Ematologia
Pavia, 27100
Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
Torino, 10126
Divisione Ematologia, Ospedale Borgo Roma
Verona, Veneto, 37134
Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
Vicenza, 36100
Germany2 sites
RWTH Aachen University
Aachen
Johannes Wesling Klinikum Minden
Minden
About this study
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.
Read more
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
- Being tested
- DOACs
- Keywords
- Efficacy and safety profile, Direct oral anticoagulants, Real world data
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOACsDrug
Also called Dabigatran, Edoxaban, Rivaroxaban, Apixaban
Direct Oral Anticoagulants
| Study group | Role | What they receive |
|---|---|---|
| MPN patients treated with DOACs | Not described Receives: Drug: DOACs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 5 year from the start of treatment with DOACs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192916
- Sponsor's protocol ID
- MPN-DOACs
- Acronym
- MPN-DOACs
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT04192916
- Acronym / sponsor ID
- MPN-DOACs / MPN-DOACs
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- Efficacy and safety profile, Direct oral anticoagulants, Real world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPN patients treated with DOACs | – | Drug: DOACs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MPN treated with any DOAC for AF or VTE
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Administration of DOAC for any medical reason other than AF and/or VTE (excluding superficial vein thrombosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOACsAlso: Dabigatran, Edoxaban, Rivaroxaban, ApixabanDirect Oral Anticoagulants | Drug | MPN patients treated with DOACs |
Primary outcome
Cumulative incidence of major thrombosis and bleeding
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, Germany, United States, Canada, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of major thrombosis and bleeding (time frame: At 5 year from the start of treatment with DOACs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.