TerminatedPhase 3

REstart or STop Antithrombotic Randomised Trial in France

Stopped: Recruitment difficulties

France23 participantsStarted 2016-12-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient age ≥18 years. * Spontaneous intracerebral hemorrhage confirmed by imaging * Patient had been taken antithrombotic drug(s) for the prevention of vaso-occlusive disease for at least 1 week before ICH onset * Randomisation more than 24 hours after ICH onset. * Patient and their doctor are uncertain about whether to start or avoid antiplatelet drugs. * Brain imaging that first diagnosed the ICH is available. Participant or representative consent. Exclusion Criteria: * intracerebral hemorrhage associated with : a vascular malformation (AVM, arterial aneurysm, cavernoma); a secondary hemorrhagic infarction; a cerebral venous thrombosis; a tumor * Patients with a formal indication of restarting oral anticoagulants despite the ICH (eg mechanical heart valves or pulmonary embolism under 6 months)

What they're measuring

Number of patients with symptomatic intracerebral hemorrhage

Timeframe: at one year

Trial details

NCT IDNCT02966119

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-07