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Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.

The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial.

Collaborators (199)

Aakvik R, Thorud HM, Iuell RS, Aarhus D, Sandset EC, Söderblom P, Nilsen EL, Hamre MB, Perry D, Thomassen J, Berge E, Sandset PM, Andersen G, Bath PM, Berge E, Boysen G, Carlberg B, Desfontaines P, Indredavik B, Iversen HK, Jatuzis D, Kjeldsen SE, Kõrv J, Lindgren A, Lüders S, Murray GD, Richter PS, Roine RO, Russell D, Sandset EC, Schrader J, Terént A, Thijs V, Thomassen L, Vanhooren G, Wahlgren NG, Wyller TB, Fransson A, Hasvold P, Karlson B, Springer B, Strandgaard S, Husted S, Salvesen R, Pedersen TR, Sandercock PA, Wedel H, Peeters A, Desfontaines P, Vanhooren G, Van Buggenhout E, Merlevede K, Thijs V, Van Landegem W, Libbrecht N, Deklippel N, Andersen G, Jeppesen LL, Ellemann K, Oskoie MZ, á Steig J, á Steig B, Iversen HK, Søsted U, Ali AM, Dorph-Petersen AM, Davidsen O, Geisler K, Rasmussen O, Groth O, Svaneborg N, Heick A, Kõrv J, Gross-Paju K, Kreis A, Antsov K, Brin V, Kaste M, Tuisku S, von Mering M, Ebke M, Schroeter A, Berlit P, Neumann-Haefelin T, Zierz S, Diener HC, Lüders S, Grüger A, Maschke M, Huber R, Hoffmann F, Griewing B, Weissenborn K, Merkelbach S, Schuster O, Rudel G, Berrouschot J, Kazlauskas H, Doviltis R, Jatuzis D, Neverdauskas V, Sceponaviciūte S, Urbutis R, Vilimas A, Jasioniene I, Juknelis K, Masiliunas L, Balkaitiene R, Asak O, Holand N, Spenning AB, Asak T, Andersen V, Siemsglüss J, Rønning Y, Overlie H, Indredavik B, Johnsen HJ, Johansen T, Louring M, Krogseth SB, Schüler S, Overbø AG, Undeland M, Larssen-Aas F, Vatn S, Vadset PT, Fossli A, Jensen S, Janusonyte K, Drottning P, Salvesen R, Berg H, Tveiten A, Aanderbakk DO, Reiten T, Midtsaether AG, Elmquist S, Oygarden O, Andersen OK, Solbakken T, Solhoff R, Lillebø ML, Lindqvist K, Rønning OM, Tobro H, Størslett B, Solberg EE, Berntsen R, Nore SP, Reichel P, Hegrestad SE, Knutsen GV, Thomassen L, Dahl A, Ibsen J, Morsund AH, Kristensen A, Krychowiak G, Sobolewski P, Brola W, Richter PS, Gasecki D, Zaborski J, Zalisz M, Kosiek S, Kwiatkowska M, Lannemyr O, Karlsson JE, Eklund B, Laska AC, Wiberg B, Kostulas K, Almgren T, Nordström I, Erikoinen T, Lökk J, Wallén T, Axelsson MB, Timberg I, Lindgren A, Bolsöy U, Gibson M, Eriksson B, Wiklund M, Ask E, Hansson PO, Janiec K, Pähn LC, Mitry H, Wahlgren NG, Gunnarsson M, Höjeberg B, Rosenqvist U, Wannberg H, Akerstedt AC, Dahlin L, Svensson R, Borenstein P.

Author information

  • 1Department of Internal Medicine, Oslo University Hospital Ullevål, Oslo, Norway.

Abstract

BACKGROUND:

Raised blood pressure is common in acute stroke, and is associated with an increased risk of poor outcomes. We aimed to examine whether careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised blood pressure.

METHODS:

Participants in this randomised, placebo-controlled, double-blind trial were recruited from 146 centres in nine north European countries. Patients older than 18 years with acute stroke (ischaemic or haemorrhagic) and systolic blood pressure of 140 mm Hg or higher were included within 30 h of symptom onset. Patients were randomly allocated to candesartan or placebo (1:1) for 7 days, with doses increasing from 4 mg on day 1 to 16 mg on days 3 to 7. Randomisation was stratified by centre, with blocks of six packs of candesartan or placebo. Patients and investigators were masked to treatment allocation. There were two co-primary effect variables: the composite endpoint of vascular death, myocardial infarction, or stroke during the first 6 months; and functional outcome at 6 months, as measured by the modified Rankin Scale. Analyses were by intention to treat. The study is registered, number NCT00120003 (ClinicalTrials.gov), and ISRCTN13643354.

FINDINGS:

2029 patients were randomly allocated to treatment groups (1017 candesartan, 1012 placebo), and data for status at 6 months were available for 2004 patients (99%; 1000 candesartan, 1004 placebo). During the 7-day treatment period, blood pressures were significantly lower in patients allocated candesartan than in those on placebo (mean 147/82 mm Hg [SD 23/14] in the candesartan group on day 7 vs 152/84 mm Hg [22/14] in the placebo group; p<0·0001). During 6 months' follow-up, the risk of the composite vascular endpoint did not differ between treatment groups (candesartan, 120 events, vs placebo, 111 events; adjusted hazard ratio 1·09, 95% CI 0·84-1·41; p=0·52). Analysis of functional outcome suggested a higher risk of poor outcome in the candesartan group (adjusted common odds ratio 1·17, 95% CI 1·00-1·38; p=0·048 [not significant at p≤0·025 level]). The observed effects were similar for all prespecified secondary endpoints (including death from any cause, vascular death, ischaemic stroke, haemorrhagic stroke, myocardial infarction, stroke progression, symptomatic hypotension, and renal failure) and outcomes (Scandinavian Stroke Scale score at 7 days and Barthel index at 6 months), and there was no evidence of a differential effect in any of the prespecified subgroups. During follow-up, nine (1%) patients on candesartan and five (<1%) on placebo had symptomatic hypotension, and renal failure was reported for 18 (2%) patients taking candesartan and 13 (1%) allocated placebo.

INTERPRETATION:

There was no indication that careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised blood pressure. If anything, the evidence suggested a harmful effect.

FUNDING:

South-Eastern Norway Regional Health Authority; Oslo University Hospital Ullevål; AstraZeneca; Takeda.

Copyright © 2011 Elsevier Ltd. All rights reserved.

Comment in

PMID:
21316752
[PubMed - indexed for MEDLINE]
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