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Blood pressure lowering for the secondary prevention of stroke: rationale and design for PROGRESS
1PROGRESS International Coordinating Centre, Department of Medicine, University of Auckland, New Zealand.
Insights
Blood pressure reduction significantly lowers stroke risk in patients with prior cerebrovascular disease. The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) evaluated this effect using an ACE inhibitor-based regimen.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Clinical Trials
Background:
- Elevated blood pressure is a known risk factor for initial and recurrent strokes.
- While blood pressure reduction benefits hypertensive patients, its effect on those with existing cerebrovascular disease remains unclear.
- Patients with a history of stroke or transient ischemic attack face particularly high risks.
Purpose of the Study:
- To determine the impact of blood pressure reduction on stroke risk in patients with a history of cerebrovascular disease.
- To assess the efficacy of an angiotensin-converting enzyme (ACE) inhibitor-based regimen in preventing recurrent strokes.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 6000 patients with a recent history of transient ischemic attack or stroke.
- Patients received either perindopril (with or without indapamide) or matching placebos for a minimum of 4 years.
- Recruitment occurred across international clinical centers.
Main Results:
- Stroke is the primary endpoint.
- Secondary outcomes include fatal or disabling strokes, major cardiovascular events, cardiovascular deaths, and dementia.
Conclusions:
- The study aims to provide crucial data on the benefits of blood pressure management in a high-risk population.
- Findings will inform clinical guidelines for secondary stroke prevention.
Background:
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.
Design And Treatment:
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.
Patients:
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.
Major Outcomes:
Stroke is the primary study outcome, and secondary outcomes include fatal or disabling strokes, total major cardiovascular events, cardiovascular deaths and dementia.