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)

Else Charlotte Sandset, Gordon Murray, Gudrun Boysen, Dalius Jatuzis, Janika Kõrv, Stephan Lüders, Przemyslaw S Richter, Risto O Roine, Andreas Terént, Vincent Thijs, Eivind Berge, SCAST Study Group, Helle Klingenberg Iversen

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18 Citations (Scopus)

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.

AIMS AND DESIGN: 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.

STUDY OUTCOMES: 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

FUNDING: 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.

SUMMARY: 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.

Original languageEnglish
JournalInternational journal of stroke : official journal of the International Stroke Society
Volume5
Issue number5
Pages (from-to)423-7
Number of pages5
DOIs
Publication statusPublished - Oct 2010

Keywords

  • Angiotensin II Type 1 Receptor Blockers
  • Benzimidazoles
  • Double-Blind Method
  • Humans
  • Hypertension
  • Research Design
  • Scandinavian and Nordic Countries
  • Stroke
  • Tetrazoles

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