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. 2017 May 25;2017(5):CD012144. doi: 10.1002/14651858.CD012144.pub2

RESTART.

Trial name or title REstart or STop Antithrombotics Randomised Trial (RESTART)
Methods Allocation: randomised
Blinding: treatment is open‐label, but outcome assessors are blinded
Duration: at least 6 months
Design: parallel
Setting: UK National Health Service (NHS) secondary care (inpatient and outpatient services in stroke, neurology and neurosurgery) and primary care
Dates: May 2013 to May 2018 (recruitment), November 2018
Participants Inclusion criteria:
  • Patient age ≥ 18 years.

  • Spontaneous primary or secondary ICH.

  • Patient had taken antithrombotic drug(s) for the prevention of vaso‐occlusive disease before ICH onset. Randomisation > 24 hours after ICH onset.

  • Patient and their doctor are uncertain about whether to start or avoid antiplatelet drugs.

  • Patient is registered with a general practitioner (GP).

  • Brain imaging that first diagnosed the ICH is available.

  • Participant or representative consent.


Exclusion criteria:
  • ICH due to preceding trauma or haemorrhagic transformation of ischaemic stroke.

  • Patient is taking an anticoagulant drug following ICH.

  • Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.

  • Patient is being treated or followed up in another CTIMP.

  • Patient and carer unable to understand spoken or written English.


Brain magnetic resonance imaging (MRI) sub‐study: MRI done after ICH but before randomisation. No claustrophobia. MRI not contraindicated
Interventions Participants will be randomised to either 'start antiplatelet medication' (restricted to the use of 1 or more of aspirin, dipyridamole or clopidogrel at the investigator's discretion) or "avoid antiplatelet medication"
Outcomes Primary outcome measure: recurrent symptomatic ICH
Secondary outcome measures:
  • possible recurrent ICH;

  • symptomatic non‐fatal extracerebral haemorrhage, extracranial haemorrhage, and vaso‐occlusive events; death;

  • modified Rankin Scale score;

  • adherence to antiplatelet drug(s)

Starting date April 2013
Contact information UK Chief Investigator: Rustam Al‐Shahi Salman; Trial Manager: Karen Innes
RESTART.trial@ed.ac.uk.
Notes