title: The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2).
abstract: BACKGROUND
  The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure lowering and effects on haematoma expansion within 6 h of onset of intracerebral haemorrhage. This article describes the design of the second, main phase, INTERACT2.
  
  
  OBJECTIVE
  To compare the effects of a management strategy of early intensive blood pressure lowering with a more conservative guideline-based blood pressure management policy in patients with acute intracerebral hemorrhage.
  
  
  METHODS
  INTERACT2 is a prospective, randomized, open label, assessor-blinded end-point (PROBE). Patients with a systolic blood pressure greater than 150 mmHg and no definite indication for or contraindication to blood pressure-lowering treatment are centrally randomised to either of two treatment groups within 6 h onset of intracerebral haemorrhage. Those allocated to intensive blood pressure lowering will receive primarily intravenous, hypotensive agents to achieve a systolic blood pressure target of <140 mmHg within 1 h of randomisation and to maintain this level for up to 7 days in hospital. The control group will receive blood pressure-lowering treatment to a target systolic blood pressure of <180 mmHg. Both groups are to receive similar acute stroke unit care, therapy and active management. Oral antihypertensive therapy is recommended in patients before hospital discharge with a long-term systolic blood pressure goal of 140 mmHg according to secondary stroke prevention guidelines. A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (alpha 0.05) to detect a 14% difference in the risk of death and dependency between the groups, which equates to one or more cases of a poor outcome prevented in every 15 patients treated.
  
  
  RESULTS
  The primary outcome is the combined end-point of death and dependency according to the modified Rankin Scale at 90 days. The secondary outcomes are the separate components of the primary end-point in patients treated <4 hours of ICH onset, grades of physical function on the modified Rankin Scale, health-related quality of life on the EuroQoL, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care and unexpected serious adverse events.
authors.affiliation: The George Institute for International Health, Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Delcourt
authors.forename: Y
authors.initials: Y
authors.lastname: Huang
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: E
authors.initials: E
authors.lastname: Heeley
authors.forename: R
authors.initials: R
authors.lastname: Lindley
authors.forename: C
authors.initials: C
authors.lastname: Stapf
authors.forename: C
authors.initials: C
authors.lastname: Tzourio
authors.forename: H
authors.initials: H
authors.lastname: Arima
authors.forename: M
authors.initials: M
authors.lastname: Parsons
authors.forename: J
authors.initials: J
authors.lastname: Sun
authors.forename: B
authors.initials: B
authors.lastname: Neal
authors.forename: J
authors.initials: J
authors.lastname: Chalmers
authors.forename: C
authors.initials: C
authors.lastname: Anderson
mesh_terms: D000328:Adult; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D018401:Sample Size; D020521:Stroke / Q000188:drug therapy* / Q000503:physiopathology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents