Clinical Trial: REstart or STop Antithrombotic Randomised Trial in France

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Antithrombo

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 Summary:

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.


Sponsor: University Hospital, Lille

Current Primary Outcome: Number of patients with symptomatic intracerebral hemorrhage [ Time Frame: at one year ]

Occurrence of a fatal or non-fatal symptomatic ICH proven radiologically at follow-up ( brain CT or MRI) .


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • serious fatal vascular events (i.e. followed by death within 30 days ) or non- fatal [ Time Frame: 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 [ Time Frame: at one year and at the end of follow-up (2 years) ]
    Death without pre-defined vascular cause
  • Rankin Scale [ Time Frame: 2 years ]
    modified Rankin Scale: dichotomized mRS 0-1-2 (no dependency) versus 3 or more (dependency or death)


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: July 13, 2016
Date Started: December 7, 2016
Date Completion: November 2019
Last Updated: May 18, 2017
Last Verified: May 2017