title: Angiotensin receptor blockade in acute stroke. The Scandinavian Candesartan Acute Stroke Trial: rationale, methods and design of a multicentre, randomised- and placebo-controlled clinical trial (NCT00120003).
abstract: BACKGROUND
  Elevated blood pressure following acute stroke is common, and yet early antihypertensive treatment is controversial. ACCESS suggested a beneficial effect of the angiotensin receptor blocker candesartan in the acute phase of stroke, but these findings need to be confirmed in new, large trials.
  
  
  OBJECTIVE
  The Scandinavian Candesartan Acute Stroke Trial is an international randomised, placebo-controlled, double-blind trial of candesartan in acute stroke. We plan to recruit 2500 patients presenting within 30 h of stroke (ischaemic or haemorrhagic) and with systolic blood pressure ≥140 mmHg. The recruited patients are randomly assigned to candesartan or placebo for 7-days (doses increasing from 4 to 16 mg once daily). Randomisation is performed centrally via a secure web interface. The follow-up period is 6-months. Patients are included from the following nine North-European countries: Norway, Sweden, Denmark, Belgium, Germany, Poland, Lithuania, Estonia and Finland.
  
  
  RESULTS
  There are two co-primary effect variables: • Functional status at 6-months, measured by the modified Rankin Scale, and • vascular death, myocardial infarction or stroke during the first 6-months. Secondary outcome variables: Secondary effect variables include • the Barthel index (functional status) • EuroQol (quality of life) and • Mini-mental state examination (cognition) at 6-months • Health economic costs during the first 6-months
  
  
  BACKGROUND
  The Scandinavian Candesartan Acute Stroke Trial receives basic funding from Norwegian health authorities. AstraZeneca supplies the trial drugs, and AstraZeneca and Takeda support the trial with limited, unrestricted grants.
  
  
  CONCLUSIONS
  The Scandinavian Candesartan Acute Stroke Trial is the first large trial of angiotensin receptor blockers in patients with elevated blood pressure and acute stroke, and aims to answer whether treatment with angiotensin receptor blockers is beneficial for this indication.
authors.affiliation: Department of Internal Medicine, Oslo University Hospital Ulleval, Oslo, Norway. e.c.sandset@medisin.uio.no
authors.forename: Else Charlotte
authors.initials: EC
authors.lastname: Sandset
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.forename: Gudrun
authors.initials: G
authors.lastname: Boysen
authors.forename: Dalius
authors.initials: D
authors.lastname: Jatuzis
authors.forename: Janika
authors.initials: J
authors.lastname: Kõrv
authors.forename: Stephan
authors.initials: S
authors.lastname: Lüders
authors.forename: Przemyslaw S
authors.initials: PS
authors.lastname: Richter
authors.forename: Risto O
authors.initials: RO
authors.lastname: Roine
authors.forename: Andreas
authors.initials: A
authors.lastname: Terént
authors.forename: Vincent
authors.initials: V
authors.lastname: Thijs
authors.forename: Eivind
authors.initials: E
authors.lastname: Berge
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D001713:Biphenyl Compounds; D004311:Double-Blind Method; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy; D012107:Research Design; D012537:Scandinavian and Nordic Countries; D020521:Stroke / Q000150:complications / Q000188:drug therapy*; D013777:Tetrazoles / Q000627:therapeutic use*
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C081643:candesartan