The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial
The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial
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DOI：
10.1016/s0140-6736(11)60104-9
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发表时间：
2011-02-01
期刊：
影响因子：
168.9
通讯作者：
Berge, Eivind
中科院分区：
文献类型：
--
作者：
Sandset, Else Charlotte;Bath, Philip M. W.;Berge, Eivind
背景：血压升高在急性卒中中很常见，并且与不良结局的风险增加相关。我们的目的是研究是否仔细降压治疗与血管紧张素受体阻滞剂坎地沙坦是有益的急性中风和血压升高的患者，在这个随机，安慰剂对照，双盲试验的参与者被招募从146个中心在9个北欧国家。年龄大于18岁的急性卒中（缺血性或出血性）和收缩压≥ 140 mm Hg的患者在症状发作后30 h内入选。患者随机分配至坎地沙坦或安慰剂组（1：1），持续7天，剂量从第1天的4 mg增加至第3 - 7天的16 mg。随机化按中心分层，分为6包坎地沙坦或安慰剂组。患者和研究者均对治疗分配设盲。有两个共同主要效应变量：前6个月内血管性死亡、心肌梗死或卒中的复合终点;以及6个月时的功能结局，采用改良兰金量表测量。研究登记号为NCT 00120003（ClinicalTrials.gov），ISRCTN 13643354。结果2029例患者被随机分配到治疗组（坎地沙坦组1017例，安慰剂组1012例），2004例患者6个月时的状态数据可用（99%;坎地沙坦组1000例，安慰剂组1004例）。在7天的治疗期间，坎地沙坦组患者的血压显著低于安慰剂组患者（坎地沙坦组第7天的平均血压为147/82 mmHg [SD 23/14]，安慰剂组为152/84 mmHg [SD 22/14]; p
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