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REstart or STop Antithrombotic Randomised Trial in France

NCT02966119 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-05-09

No results posted yet for this study

Summary

RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ICH.

RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

Conditions

  • Cerebral Hemorrhage

Interventions

DRUG

Clopidogrel or Aspirin and/or Dypyridamole

The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm " restart"

Sponsors & Collaborators

  • Région Hauts de France, France

    collaborator UNKNOWN

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Charlotte CORDONNIER, MD, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-07
Primary Completion
2019-12-07
Completion
2019-12-07

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 NCT02966119 on ClinicalTrials.gov