Clinical trial NCT02966119: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cerebral Hemorrhage
Keywords: stroke
intracranial hemorrhage
intracerebral hemorrhage
antithrombotic drugs
brain microbleeds
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Région Hauts de France, France
name: Ministry of Health, France
First posted: 2016-11-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of patients with symptomatic intracerebral hemorrhage
timeFrame: at one year
Secondary outcomes:
measure: serious fatal vascular events (i.e. followed by death within 30 days ) or non- fatal
timeFrame: at one year and at the end of follow-up (2 years)
measure: Other fatal events
timeFrame: at one year and at the end of follow-up (2 years)
measure: Rankin Scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Charlotte CORDONNIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.