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PROGRESS - Perindopril Protection Against Recurrent Stroke Study: characteristics of the study population at
Insights
The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) investigated if an ACE-inhibitor-based regimen reduces stroke risk in patients with prior stroke or TIA. Results indicate the study is on track to meet its primary objective.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Pharmacology
Background:
- Stroke and transient ischemic attack (TIA) represent significant public health concerns.
- Effective long-term blood pressure management is crucial for secondary prevention of cerebrovascular events.
Purpose of the Study:
- To evaluate the efficacy of an angiotensin-converting enzyme (ACE) inhibitor-based regimen in reducing recurrent stroke risk.
- To assess the impact of this treatment on overall cardiovascular events, dementia, and disability.
Main Methods:
- A double-blind, placebo-controlled randomized trial involving 6105 patients.
- Participants received either perindopril (with or without indapamide) or matching placebo.
- Inclusion criteria encompassed both hypertensive and non-hypertensive patients with a history of stroke or TIA.
Main Results:
- Recruitment concluded in November 1997, with a mean participant age of 64 years.
- 84% of participants had a history of stroke, with the remainder having TIA alone.
- Baseline blood pressure averaged 147/86 mm Hg; 58% received combination therapy (perindopril and indapamide).
Conclusions:
- Recruitment completion and statistical power indicators suggest the study will meet its primary objective.
- The PROGRESS trial is well-positioned to provide significant insights into stroke prevention strategies.
Objective:
The primary aim of the Perindopril Protection Against Recurrent Stroke Study (PROGRESS) is to determine the effects of a long-term angiotensin converting enzyme (ACE)-inhibitor-based blood-pressure-lowering regimen on the risk of stroke among patients with a history of stroke or transient ischaemic attack (TIA). Secondary aims include investigation of the effects of treatment on total cardiovascular events, dementia and disability.
Design And Methods:
PROGRESS is a double-blind, placebo-controlled randomized trial. Patients were randomly assigned to treatment with the ACE inhibitor perindopril (and the diuretic indapamide for those with no definite indication or contraindication to treatment with a diuretic) versus matching placebo(s). Both hypertensive and non-hypertensive patients were eligible for inclusion. Follow-up is scheduled for completion in 2001. The study is being conducted in 172 centres in 10 countries (Australia, Belgium, China, France, Italy, Ireland, Japan, New Zealand, Sweden and the United Kingdom).
Results:
Recruitment was completed in November 1997, with 6105 patients randomized. Mean age of participants at study entry was 64 years, 30% of whom were female, 84% had an entry diagnosis of stroke, and the remainder had an entry diagnosis of TIA alone. Mean baseline blood pressure was 147/86 mm Hg, with about half the patients reporting current drug treatment for hypertension. At randomization, 58% of patients were assigned to combination treatment with both study drugs versus placebos, and 42% were assigned to perindopril alone versus placebo.
Conclusions:
The successful completion of recruitment, together with current indicators of statistical power, suggest that PROGRESS should achieve its primary aim on schedule.