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

• ClinicalTrials.gov Identifier: NCT02966119
• Recruitment Status: Terminated
• First Posted: November 17, 2016
• Last Update Posted: May 9, 2022
• Sponsor: University Hospital, Lille
• Collaborators: Région Hauts de France, France; Ministry of Health, France
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: July 13, 2016
• First Posted Date: November 17, 2016
• Last Update Posted Date: May 9, 2022
• Actual Study Start Date: December 7, 2016
• Actual Primary Completion Date: December 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 14, 2016)

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 Measures: Same as current

Current Secondary Outcome Measures (submitted: November 14, 2016)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: REstart or STop Antithrombotic Randomised Trial in France
• 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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Cerebral Hemorrhage

Intervention

Drug: Clopidogrel or Aspirin and/or Dypyridamole

The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm " restart"

Study Arms

• 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
  Intervention: Drug: Clopidogrel or Aspirin and/or Dypyridamole
• 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

• Publications *: Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7. No abstract available.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 3, 2022): 23
• Original Estimated Enrollment (submitted: November 14, 2016): 292
• Actual Study Completion Date: December 7, 2019
• Actual Primary Completion Date: December 7, 2019 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02966119
• Other Study ID Numbers: 2015_11; 2015-A01319-40 ( Other Identifier: ID-RCB number, ANSM ); PHRCI_2014 ( Other Identifier: PHRC number, DGOS )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: we plan to make IPD analysis with sister trial: RESTART UK

• Current Responsible Party: University Hospital, Lille
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Lille
• Original Study Sponsor: Same as current

Collaborators

• Région Hauts de France, France
• Ministry of Health, France

Investigators

• Principal Investigator: Charlotte CORDONNIER, MD, PhD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: May 2022