PROGRESS: Perindopril Protection Against Recurrent Stroke Study: status in March 1997

Abstract

Main objective: 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.

Study design: 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.

Methodology: 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.

Results: 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.

Conclusions: 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.