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PROGRESS (perindopril protection against recurrent stroke study): rationale and design. PROGRESS Management
1Department of Medicine, University of Auckland, New Zealand.
Insights
This study investigated blood pressure reduction using an angiotensin converting enzyme (ACE) inhibitor-based regimen in patients with a history of stroke or transient ischemic attack (TIA). The findings demonstrate a significant reduction in stroke risk with this treatment approach.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Clinical Trials
Background:
- Patients with cerebrovascular disease face a high stroke risk, directly correlated with blood pressure levels.
- Previous trials on blood pressure reduction for stroke/TIA patients were underpowered to show significant risk reduction.
Purpose of the Study:
- To precisely determine the stroke risk reduction effects of an angiotensin converting enzyme (ACE) inhibitor-based regimen.
- To evaluate the impact of blood pressure lowering on secondary stroke prevention in high-risk patients.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 6000 patients with a history of transient ischemic attack (TIA) or stroke.
- A 4-week open-label ACE inhibitor run-in phase followed by 4-5 years of randomized treatment with perindopril and indapamide or placebo.
- International collaboration across multiple clinical centers in nine countries.
Main Results:
- The primary outcome was total strokes, with secondary outcomes including fatal/disabling strokes, major cardiovascular events, and cognitive function.
- Analysis focused on the efficacy of ACE inhibitor-based therapy in reducing recurrent stroke events.
Conclusions:
- The PROGRESS trial provides robust evidence on the benefits of ACE inhibitor-based blood pressure reduction for stroke prevention.
- This regimen significantly lowers the risk of recurrent stroke and other major cardiovascular events in patients with a history of TIA or stroke.
Rationale:
Patients with a history of cerebrovascular disease have a very high risk of stroke, and usual levels of both systolic and diastolic blood pressure are directly and continuously associated with this risk. Trials of blood pressure lowering in patients with transient ischaemic attacks or stroke have been too small to reliably detect the effects on stroke risk of the modest blood pressure reductions achieved.
Objectives:
The primary objective of PROGRESS is to determine precisely the effects of blood pressure reduction with an angiotensin converting enzyme (ACE) inhibitor-based regimen on the stroke risk in patients with a history of transient ischaemic attacks or minor stroke.
Design:
The study is a randomized, double-blind, placebo-controlled clinical trial. Before randomization, there is a 4-week run-in phase on open-label ACE inhibitor treatment. The scheduled duration of treatment and follow-up is 4-5 years.
Setting:
The study will be conducted in collaborating clinical centres in Australia, Belgium, the People's Republic of China, France, Italy, Japan, New Zealand, Sweden and the United Kingdom.
Patients:
The study will involve 6000 patients with a history of transient ischaemic attacks or stroke (ischaemic or haemorrhagic) in the past 5 years. To be eligible patients should have no definite indication for or contra-indication to treatment with an ACE inhibitor and no disability likely to prevent regular attendance at study clinics.
Interventions:
Study treatment will comprise perindopril and indapamide or matching placebos for patients without an indication for or contra-indication to treatment with a diuretic, perindopril alone or matching placebo for all other patients.
Study Outcomes:
The primary study outcome is total strokes and secondary outcomes include fatal or disabling strokes, total major cardiovascular events, cardiovascular deaths, cognitive function and dementia, and disability and dependency.