REstart or STop Antithrombotic Randomised Trial in France

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

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

  • Drug: Clopidogrel or Aspirin and/or Dypyridamole
    • The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm ” restart”

Arms, Groups and Cohorts

  • Experimental: Start antiplatelet drug(s)
    • 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
  • No Intervention: Avoid antiplatelet drug(s)
    • If the patient is randomized in this arm, antiplatelet drugs will not be prescribed to the patient during the entire study period

Clinical Trial Outcome Measures

Primary Measures

  • 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) .

Secondary Measures

  • 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Région Hauts de France, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charlotte CORDONNIER, MD, PhD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Hilde Henon, MD, PhD, hilde.henon@chru-lille.fr

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