REstart or STop Antithrombotic Randomised Trial in France

NCT02966119 | Terminated Phase 3 DMC

• 3 other identifiers: 2015_112015-A01319-40PHRCI_2014
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Hemorrhage

Keywords

stroke; intracranial hemorrhage; intracerebral hemorrhage; antithrombotic drugs; brain microbleeds

Outcome Measures

Primary Outcomes (1)

• Number of patients with symptomatic intracerebral hemorrhage

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

  at one year

Secondary Outcomes (3)

• 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)

• Other fatal events

  at one year and at the end of follow-up (2 years)

• Rankin Scale

  2 years

Study Arms (2)

Start antiplatelet drug(s)

EXPERIMENTAL

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

Avoid antiplatelet drug(s)

NO INTERVENTION

If the patient is randomized in this arm, antiplatelet drugs will not be prescribed to the patient during the entire study period

Interventions

Clopidogrel or Aspirin and/or Dypyridamole DRUG

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

Start antiplatelet drug(s)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead
• Région Hauts de France, France: collaborator
• Ministry of Health, France: collaborator

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

Related Publications (2)

• Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.

  PMID: 36700520 DERIVED

• 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.

  PMID: 34022160 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Intracranial Hemorrhages

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charlotte CORDONNIER, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: November 17, 2016
• Study Start: December 7, 2016
• Primary Completion: December 7, 2019
• Study Completion: December 7, 2019
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)