REstart or STop Antithrombotic Randomised Trial in France

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France; Région Hauts de France, France
• Treatments: Aspirin; Clopidogrel; Platelet Aggregation Inhibitors

Criteria

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)