PROGRESS International Coordinating Centre, Department of Medicine, University of Auckland, New Zealand.
J Hypertens Suppl. 1996 Sep;14(2):S41-5; discussion S45-6.
Usual blood pressure levels have been shown to be directly and continuously associated with the risks of initial and recurrent stroke. Blood pressure lowering has been demonstrated to reduce the risk of a first stroke in hypertensive patients, but there is uncertainty about the effects of reducing blood pressure in patients with a history of cerebrovascular disease, for whom stroke risks are particularly high. The primary objective of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) is to determine the effects of blood pressure reduction on stroke risk in patients with a history of cerebrovascular disease.
PROGRESS is a randomized, double-blind, placebo-controlled clinical trial of an angiotensin converting enzyme (ACE) inhibitor-based blood pressure lowering treatment regimen. Before randomization, there is a 4-week run-in phase on open-label treatment, after which patients are assigned to continued treatment or to placebo. Following randomization, the trial treatments comprise perindopril (4 mg daily) plus indapamide (2.5 mg daily) or matching placebos for patients without an indication for or contraindication to treatment with a diuretic, and perindopril alone or matching placebo for all other patients. The scheduled duration of treatment and follow-up is a minimum of 4 years.
The study will involve 6000 patients with a proven transient ischaemic attack (including amaurosis fugax) or stroke (cerebral infarct, cerebral haemorrhage or stroke of unknown type) in the past 5 years. The patients selected will have no known definite indication for or contraindication to treatment with an ACE inhibitor and no disability likely to prevent regular attendance at study clinics. Patients will be recruited from collaborating clinical centres in Australia, Belgium, China, France, Italy, Japan, New Zealand, Sweden and the United Kingdom.
Stroke is the primary study outcome, and secondary outcomes include fatal or disabling strokes, total major cardiovascular events, cardiovascular deaths and dementia.
通常的血压水平已被证明与初发和复发性中风的风险直接且持续相关。降低血压已被证实可降低高血压患者首次中风的风险，但对于有脑血管疾病史的患者（其中风风险特别高）降低血压的效果尚不确定。培哚普利预防复发性中风研究（PROGRESS）的主要目标是确定降低血压对有脑血管疾病史患者中风风险的影响。
PROGRESS是一项基于血管紧张素转换酶（ACE）抑制剂的降压治疗方案的随机、双盲、安慰剂对照临床试验。在随机分组前，有一个为期4周的开放标签治疗导入期，之后患者被分配接受持续治疗或安慰剂治疗。随机分组后，对于无使用利尿剂治疗指征或禁忌证的患者，试验治疗包括培哚普利（每日4毫克）加吲达帕胺（每日2.5毫克）或匹配的安慰剂；对于所有其他患者，则为单独的培哚普利或匹配的安慰剂。预定的治疗和随访持续时间至少为4年。
该研究将纳入6000名在过去5年中确诊有短暂性脑缺血发作（包括一过性黑矇）或中风（脑梗死、脑出血或不明类型中风）的患者。入选的患者无已知明确的使用ACE抑制剂治疗的指征或禁忌证，且无可能妨碍定期前往研究诊所就诊的残疾情况。患者将从澳大利亚、比利时、中国、法国、意大利、日本、新西兰、瑞典和英国的合作临床中心招募。
中风是主要研究结局，次要结局包括致命性或致残性中风、主要心血管事件总数、心血管死亡和痴呆。
