PROGRESS - PERINDOPRIL PROTECTION AGAINST RECURRENT STROKE STUDY - STATUS IN JULY 1996

Objectives The primary objective of PROGRESS is to determine reliably the efficacy of lowering blood pressure for the prevention of stroke i n patients with a history of cerebrovascular disease. Design 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 enzym e inhibitor perindopril, alone or in combination with the diuretic ind apamide. Methods The study population comprises 6000 normotensive or h ypertensive patients with a history of stroke or transient ischaemic a ttack within the previous 5 years. The study is being conducted in ove r 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 plac ebo is performed by fax direct to Auckland, New Zealand. The primary s tudy outcome is total stroke and secondary outcomes include fatal or n on-fatal stroke, total major cardiovascular events and deaths, cogniti ve function and disability. Patients will be followed for a minimum of 4 years after randomization. Results By 16 July 1996, 162 local clini cal centres had been registered across the seven regions, and 1682 pat ients, 49% with a history of hypertension, had been randomly assigned to receive active treatment or placebo, with 65% allocated to the comb ination of perindopril and indapamide or double placebo, and 35% to pe rindopril alone or single placebo. Three months after randomization, t he 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 dea ths have been recorded after a total of 3174 patient-months of follow- up. Conclusions Observations made so far confirm that full recruitment into the study is feasible and that treatment with perindopril and in dapamide is well tolerated in the study population. The blood pressure differences between control and treatment groups recorded so far sugg est that the study should have the power to achieve its primary object ives, provided compliance with treatment is satisfactory and 6000 pati ents are successfully recruited and followed for 4-5 years.