J Hum Hypertens. 1998 Sep;12(9):627-9. doi: 10.1038/sj.jhh.1000677.
The study has been designed to assess the efficacy of blood pressure (BP) reduction in the prevention of stroke in patients with a history of ischaemic stroke, haemorrhagic stroke, or transient ischaemic attack.
A randomised, double-blind, placebo-controlled, international, multicentre trial of the angiotensin-converting enzyme (ACE) inhibitor perindopril, alone or in combination with the diuretic indapamide, in the secondary prevention of stroke and other major cardiovascular events.
A total of 6000 normotensive or hypertensive patients with a history of stroke or transient cerebral ischaemia within the previous 5 years will be included in the study. The study is being conducted in over 160 centres located in seven regions: Australia and New Zealand; The People's Republic of China; France and Belgium; Italy; Japan; Sweden; and the United Kingdom. The primary study outcome is the total number of strokes defined by WHO criteria. Secondary outcomes include fatal and disabling strokes, total number of cardiovascular events and deaths, cognitive function, disability, and dependency. A minimum of 4 years' follow-up is planned.
By 27 March 1997, 173 local clinical centres had been registered in seven regions. A total of 5268 patients (64% with a history of hypertension or baseline BPs above 95 mm Hg [diastolic] or 160 mm Hg [systolic]) had been randomly assigned to active treatment or placebo. After 6 months' follow-up the difference in BP between treatment and control groups was 10.2/4.5 mm Hg (systolic/diastolic). Sixty-three strokes (two fatal) and 20 myocardial infarctions (four fatal) had been recorded.
The viability of the study is now assured, with almost 90% of 6000 patients recruited. ACE therapy with perindopril is well tolerated in the studied population. The BP differences between control and treatment groups and the event rates recorded to date suggest that the study will achieve its primary objectives.
本研究旨在评估血压降低在预防有缺血性卒中、出血性卒中或短暂性脑缺血发作病史患者发生卒中方面的疗效。
一项随机、双盲、安慰剂对照的国际性多中心试验，研究血管紧张素转换酶（ACE）抑制剂培哚普利单独使用或与利尿剂吲达帕胺联合使用在卒中及其他主要心血管事件二级预防中的作用。
共有6000名在过去5年内有卒中或短暂性脑缺血病史的血压正常或高血压患者将被纳入本研究。研究在位于7个地区的160多个中心进行：澳大利亚和新西兰；中华人民共和国；法国和比利时；意大利；日本；瑞典；以及英国。主要研究结局是根据世界卫生组织标准定义的卒中总数。次要结局包括致命性和致残性卒中、心血管事件和死亡总数、认知功能、残疾和依赖情况。计划进行至少4年的随访。
截至1997年3月27日，7个地区已有173个当地临床中心登记。共有5268名患者（64%有高血压病史或基线血压高于95 mmHg[舒张压]或160 mmHg[收缩压]）被随机分配至活性治疗组或安慰剂组。随访6个月后，治疗组与对照组之间的血压差异为10.2/4.5 mmHg（收缩压/舒张压）。已记录到63例卒中（2例致命）和20例心肌梗死（4例致命）。
本研究的可行性现已得到保证，6000名患者中近90%已入组。在研究人群中，培哚普利的ACE治疗耐受性良好。对照组与治疗组之间的血压差异以及迄今记录的事件发生率表明该研究将实现其主要目标。
