J Hypertens Suppl. 1996 Dec;14(6):S47-51.
The primary objective of PROGRESS is to determine reliably the efficacy of lowering blood pressure for the prevention of stroke in patients with a history of cerebrovascular disease.
PROGRESS is a randomized, double-blind, placebo-controlled trial investigating the effects on the incidence of stroke and other major cardiovascular events and dementia of treatment with the angiotensin-converting enzyme inhibitor perindopril, alone or in combination with the diuretic indapamide.
The study population comprises 6000 normotensive or hypertensive patients with a history of stroke or transient ischaemic attack within the previous 5 years. The study is being conducted in over 160 centres in seven regions: Australia and New Zealand, The People's Republic of China, France and Belgium, Italy, Japan, Sweden and the United Kingdom. Computerized randomization to active treatment or placebo is performed by fax direct to Auckland, New Zealand. The primary study outcome is total stroke and secondary outcomes include fatal or non-fatal stroke, total major cardiovascular events and deaths, cognitive function and disability. Patients will be followed for a minimum of 4 years after randomization.
By 16 July 1996, 162 local clinical centres had been registered across the seven regions, and 1682 patients, 49% with a history of hypertension, had been randomly assigned to receive active treatment or placebo, with 65% allocated to the combination of perindopril and indapamide or double placebo, and 35% to perindopril alone or single placebo. Three months after randomization, the blood pressure difference between the treatment and control groups among the first 182 patients randomized was 11.9 mmHg (systolic) and 3.9 mmHg (diastolic). Six strokes and two non-stroke cardiovascular deaths have been recorded after a total of 3174 patient-months of follow-up.
Observations made so far confirm that full recruitment into the study is feasible and that treatment with perindopril and indapamide is well tolerated in the study population. The blood pressure differences between control and treatment groups recorded so far suggest that the study should have the power to achieve its primary objectives, provided compliance with treatment is satisfactory and 6000 patients are successfully recruited and followed for 4-5 years.
PROGRESS研究的主要目的是可靠地确定降低血压对有脑血管疾病病史患者预防中风的疗效。
PROGRESS是一项随机、双盲、安慰剂对照试验，研究血管紧张素转换酶抑制剂培哚普利单独或与利尿剂吲达帕胺联合治疗对中风及其他主要心血管事件和痴呆发病率的影响。
研究人群包括6000名血压正常或高血压且在过去5年内有中风或短暂性脑缺血发作病史的患者。该研究在七个地区的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、瑞典和英国。通过传真直接发往新西兰奥克兰进行计算机随机分组，分为活性治疗组或安慰剂组。主要研究结局是总体中风，次要结局包括致命或非致命性中风、总体主要心血管事件和死亡、认知功能和残疾。随机分组后患者将至少随访4年。
到1996年7月16日，七个地区已登记了162个当地临床中心，1682名患者（49%有高血压病史）被随机分配接受活性治疗或安慰剂，65%被分配到培哚普利和吲达帕胺联合组或双安慰剂组，35%被分配到单独使用培哚普利组或单安慰剂组。随机分组3个月后，在前182名随机分组患者中，治疗组与对照组的血压差值为收缩压11.9 mmHg，舒张压3.9 mmHg。在总共3174患者-月的随访后，记录到6例中风和2例非中风心血管死亡。
目前的观察结果证实该研究全面招募患者是可行的，并且在研究人群中培哚普利和吲达帕胺治疗耐受性良好。目前记录的对照组和治疗组之间的血压差异表明，只要治疗依从性良好且成功招募6000名患者并随访4至5年，该研究应有能力实现其主要目标。
