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Hydroxyurea Versus Aspirin and Hydroxyurea in Essential Thrombocythemia

NCT02611973 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2250

Last updated 2017-07-26

No results posted yet for this study

Summary

The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.

Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.

Conditions

  • MPN
  • Essential Thrombocythemia

Interventions

OTHER

Aspirin therapy interruption

Stop the treatment by aspirin 100mg/d in the experimental arm.

OTHER

Usual treatment by aspirin 100 mg/d in the active comparator arm

HU+ aspirin maintenance

OTHER

No interruption of aspirin in the Observational arm

patient with Contre indication to aspirin or required antithrombotic therapy

DRUG

Hydroxyurea treatment (HU)

HU maintenance

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Stéphane Giraudier, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2019-11-30
Completion
2022-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611973 on ClinicalTrials.gov