TY - JOUR
T1 - Angiotensin receptor blockade in acute stroke. The Scandinavian Candesartan Acute Stroke Trial
T2 - rationale, methods and design of a multicentre, randomised- and placebo-controlled clinical trial (NCT00120003)
AU - Sandset, Else Charlotte
AU - Murray, Gordon
AU - Boysen, Gudrun
AU - Jatuzis, Dalius
AU - Kõrv, Janika
AU - Lüders, Stephan
AU - Richter, Przemyslaw S
AU - Roine, Risto O
AU - Terént, Andreas
AU - Thijs, Vincent
AU - Berge, Eivind
AU - SCAST Study Group
AU - Iversen, Helle Klingenberg
PY - 2010/10
Y1 - 2010/10
N2 - 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-monthsFUNDING: 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.
AB - 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-monthsFUNDING: 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.
KW - Angiotensin II Type 1 Receptor Blockers
KW - Benzimidazoles
KW - Double-Blind Method
KW - Humans
KW - Hypertension
KW - Research Design
KW - Scandinavian and Nordic Countries
KW - Stroke
KW - Tetrazoles
U2 - 10.1111/j.1747-4949.2010.00473.x
DO - 10.1111/j.1747-4949.2010.00473.x
M3 - Journal article
C2 - 20854630
VL - 5
SP - 423
EP - 427
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4930
IS - 5
ER -