REstart or STop Antithrombotic Randomised Trial in France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2019-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Clopidogrel or Aspirin and/or Dypyridamole

Intervention Type DRUG

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clopidogrel or Aspirin and/or Dypyridamole

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No