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

doi:10.1111/j.1747-4949.2010.00473.x

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

Department of Clinical Medicine

17 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 language	English
Journal	International journal of stroke : official journal of the International Stroke Society
Volume	5
Issue number	5
Pages (from-to)	423-7
Number of pages	5
DOIs	https://doi.org/10.1111/j.1747-4949.2010.00473.x
Publication status	Published - 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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Sandset, E. C., Murray, G., Boysen, G., Jatuzis, D., Kõrv, J., Lüders, S., Richter, P. S., Roine, R. O., Terént, A., Thijs, V., Berge, E., SCAST Study Group, & Iversen, H. K. (2010). 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). International journal of stroke : official journal of the International Stroke Society, 5(5), 423-7. https://doi.org/10.1111/j.1747-4949.2010.00473.x

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). / Sandset, Else Charlotte; Murray, Gordon; Boysen, Gudrun et al.

In: International journal of stroke : official journal of the International Stroke Society, Vol. 5, No. 5, 10.2010, p. 423-7.

Research output: Contribution to journal › Journal article › Research › peer-review

Sandset, EC, Murray, G, Boysen, G, Jatuzis, D, Kõrv, J, Lüders, S, Richter, PS, Roine, RO, Terént, A, Thijs, V, Berge, E, SCAST Study Group & Iversen, HK 2010, '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)', International journal of stroke : official journal of the International Stroke Society, vol. 5, no. 5, pp. 423-7. https://doi.org/10.1111/j.1747-4949.2010.00473.x

Sandset EC, Murray G, Boysen G, Jatuzis D, Kõrv J, Lüders S et al. 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). International journal of stroke : official journal of the International Stroke Society. 2010 Oct;5(5):423-7. doi: 10.1111/j.1747-4949.2010.00473.x

Sandset, Else Charlotte ; Murray, Gordon ; Boysen, Gudrun et al. / 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). In: International journal of stroke : official journal of the International Stroke Society. 2010 ; Vol. 5, No. 5. pp. 423-7.

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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-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.",

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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

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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.

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KW - Benzimidazoles

KW - Double-Blind Method

KW - Humans

KW - Hypertension

KW - Research Design

KW - Scandinavian and Nordic Countries

KW - Stroke

KW - Tetrazoles

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