REstart or STop Antithrombotic Randomised Trial in France

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Benefit/Risk Ratio of Restarting or Avoiding Antiplatelet Drugs in Patients Who Had a Spontaneous Intracerebral Hemorrhage While Treated With Antithrombotic Drugs : RESTART-FR Study

Conditions
-----------------
Cerebral Hemorrhage

Intervention / Treatment
-----------------
* Drug: Clopidogrel or Aspirin and/or Dypyridamole


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Start antiplatelet drug(s)<br>If the patient is randomized in this arm, an antiplatelet agent (aspirin or clopidogrel or dypyridamole), chosen by the patient's physician before the randomisation, will be prescribed to the patient during the study period | Drug: Clopidogrel or Aspirin and/or Dypyridamole<br>* The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm  restart<br>|
| No Intervention: Avoid antiplatelet drug(s)<br>If the patient is randomized in this arm, antiplatelet drugs will not be prescribed to the patient during the entire study period | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with symptomatic intracerebral hemorrhage | Occurrence of a fatal or non-fatal symptomatic ICH proven radiologically at follow-up ( brain CT or MRI) . | at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious fatal vascular events (i.e. followed by death within 30 days ) or non- fatal | symptomatic hemorrhagic events, symptomatic ischemic events, stroke of undetermined nature | at one year and at the end of follow-up (2 years) | 
| Other fatal events | Death without pre-defined vascular cause | at one year and at the end of follow-up (2 years) | 
| Rankin Scale | modified Rankin Scale: dichotomized mRS 0-1-2 (no dependency) versus 3 or more (dependency or death) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, intracranial hemorrhage, intracerebral hemorrhage, antithrombotic drugs, brain microbleeds