REstart or STop Antithrombotic Randomised Trial in France

Cerebral Hemorrhage Clinical Trial

— RESTART-Fr  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02966119
• Other study ID #: 2015_11
• Secondary ID: 2015-A01319-40PH
• Status: Terminated
• Phase: Phase 3
• Start date: December 7, 2016
• Est. completion date: December 7, 2019

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 7, 2019
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• 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"

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France, Région Hauts de France, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	serious fatal vascular events (i.e. followed by death within 30 days ) or non- fatal	symptomatic hemorrhagic events, symptomatic ischemic events, stroke of undetermined nature	at one year and at the end of follow-up (2 years)
Secondary	Other fatal events	Death without pre-defined vascular cause	at one year and at the end of follow-up (2 years)
Secondary	Rankin Scale	modified Rankin Scale: dichotomized mRS 0-1-2 (no dependency) versus 3 or more (dependency or death)	2 years