The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

Trials. 2019 Mar 25;20(1):183. doi: 10.1186/s13063-019-3270-2.

Abstract

Background: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy.

Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan.

Discussion: Final results of RESTART will be analysed and disseminated in May 2019.

Trial registration: ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

Keywords: Secondary prevention; antiplatelet therapy; intracerebral haemorrhage; randomised controlled trial; statistical analysis plan; stroke.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Anticoagulants / administration & dosage
  • Anticoagulants / adverse effects
  • Cerebral Hemorrhage / chemically induced
  • Cerebral Hemorrhage / diagnostic imaging
  • Cerebral Hemorrhage / drug therapy*
  • Data Interpretation, Statistical
  • Drug Administration Schedule
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Humans
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / adverse effects
  • Randomized Controlled Trials as Topic
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Secondary Prevention / methods*
  • Secondary Prevention / statistics & numerical data
  • Stroke / chemically induced
  • Stroke / diagnostic imaging
  • Stroke / drug therapy*
  • Time Factors
  • Treatment Outcome

Substances

  • Anticoagulants
  • Fibrinolytic Agents
  • Platelet Aggregation Inhibitors