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

U

University Hospital, Lille

Status and phase

Terminated
Phase 3

Conditions

Cerebral Hemorrhage

Treatments

Drug: Clopidogrel or Aspirin and/or Dypyridamole

Study type

Interventional

Funder types

Other

Identifiers

NCT02966119
2015_11
PHRCI_2014 (Other Identifier)
2015-A01319-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Start antiplatelet drug(s)
Experimental group
Description:
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
Treatment:
Drug: Clopidogrel or Aspirin and/or Dypyridamole
Avoid antiplatelet drug(s)
No Intervention group
Description:
If the patient is randomized in this arm, antiplatelet drugs will not be prescribed to the patient during the entire study period

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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