REstart or STop Antithrombotic Randomised Trial in France "RESTART-Fr"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Clopidogrel or Aspirin and/or Dypyridamole Drug
    Intervention Desc: The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm " restart"
    ARM 1: Kind: Experimental
    Label: Start antiplatelet drug(s)
    Description: 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

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of patients with symptomatic intracerebral hemorrhage at one year
Secondary 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)
Secondary Other fatal events at one year and at the end of follow-up (2 years)
Secondary Rankin Scale 2 years

Sponsors