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REstart or STop Antithrombotic Randomised Trial in France (RESTART-Fr)

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ClinicalTrials.gov Identifier: NCT02966119
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Région Hauts de France, France
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Drug: Clopidogrel or Aspirin and/or Dypyridamole Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 7, 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Other fatal events [ Time Frame: at one year and at the end of follow-up (2 years) ]
    Death without pre-defined vascular cause

  3. Rankin Scale [ Time Frame: 2 years ]
    modified Rankin Scale: dichotomized mRS 0-1-2 (no dependency) versus 3 or more (dependency or death)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966119


Contacts
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Contact: Hilde Henon, MD, PhD hilde.henon@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHRU de Lille Recruiting
Lille, France
Principal Investigator: Hilde Henon, MD         
Sub-Investigator: Charlotte Cordonnier, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Région Hauts de France, France
Ministry of Health, France
Investigators
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Principal Investigator: Charlotte CORDONNIER, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02966119     History of Changes
Other Study ID Numbers: 2015_11
2015-A01319-40 ( Other Identifier: ID-RCB number, ANSM )
PHRCI_2014 ( Other Identifier: PHRC number, DGOS )
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we plan to make IPD analysis with sister trial: RESTART UK

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
stroke
intracranial hemorrhage
intracerebral hemorrhage
antithrombotic drugs
brain microbleeds

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists