Cerebral Hemorrhage
Conditions
Keywords
stroke, intracranial hemorrhage, intracerebral hemorrhage, antithrombotic drugs, brain microbleeds
Brief 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.
Detailed description
More than one third of the adults with a stroke due to bleeding into the brain - known as brain haemorrhage - are taking drugs to prevent clotting when they have a brain haemorrhage. These patients had previously suffered illnesses like angina, heart attack, or stroke due to blood vessel blockage, which is why they are treated with drugs to prevent further clots occurring. These drugs are usually stopped when the brain haemorrhage occurs. But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to restart these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again. In this preliminary study of 292 such people who survive a brain haemorrhage, we will study the potentially beneficial effects of three antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen by the patient's physician) on the risks of heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again.
Interventions
DRUGClopidogrel or Aspirin and/or Dypyridamole
The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm restart
Sponsors
Région Hauts de France, France
Ministry of Health, France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with symptomatic intracerebral hemorrhage | at one year | Occurrence of a fatal or non-fatal symptomatic ICH proven radiologically at follow-up ( brain CT or MRI) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serious fatal vascular events (i.e. followed by death within 30 days ) or non- fatal | at one year and at the end of follow-up (2 years) | symptomatic hemorrhagic events, symptomatic ischemic events, stroke of undetermined nature |
| Other fatal events | at one year and at the end of follow-up (2 years) | Death without pre-defined vascular cause |
| Rankin Scale | 2 years | modified Rankin Scale: dichotomized mRS 0-1-2 (no dependency) versus 3 or more (dependency or death) |
Countries
France
Outcome results
None listed