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NCT04192916 · ClinicalTrials.gov registry record
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
A clinical trial, sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS.
- Completed
- Registry status
- 442
- Enrollment target
NCT04192916 is a clinical trial that has completed, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS. The registered enrollment target is 442 participants.
The verdict
NCT04192916 has completed, sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS.
- COMPLETED
- Registry status
- 442 participants
- Enrollment target
Study 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.
Interventions
- DRUG DOACs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2020-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04192916
The ClinicalTrials.gov registry entry for NCT04192916 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 442 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DOACs is the first listed.
NCT04192916 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04192916 about?
NCT04192916 is a clinical study titled "Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms". 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...
What is the current status of trial NCT04192916?
This trial is currently completed. The enrollment target is 442 participants. The study started on 2019-09-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT04192916?
The interventions under investigation include: DOACs (DRUG).
Who is sponsoring clinical trial NCT04192916?
This trial is sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS, which has 3 total clinical trials registered on ClinicalTrials.gov.
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