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PROGRESS--perindopril protection against recurrent stroke study: status in July 1996. PROGRESS Management Committee
Insights
The PROGRESS trial investigates if lowering blood pressure with perindopril and indapamide prevents stroke in patients with cerebrovascular disease. Early results show significant blood pressure reduction and good tolerability, suggesting the study can meet its objectives.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Clinical Trials
Background:
- Stroke prevention is a critical public health concern, particularly in patients with a history of cerebrovascular disease.
- Effective blood pressure management is key to reducing stroke incidence and improving patient outcomes.
Purpose of the Study:
- To determine the efficacy of blood pressure lowering for stroke prevention in patients with a history of cerebrovascular disease.
- To investigate the effects of perindopril, alone or with indapamide, on stroke incidence, cardiovascular events, and dementia.
Main Methods:
- Randomized, double-blind, placebo-controlled trial (PROGRESS) involving 6000 patients with a history of stroke or transient ischemic attack.
- Patients received perindopril (angiotensin-converting enzyme inhibitor) with or without indapamide (diuretic) or placebo.
- Primary outcome: total stroke; secondary outcomes: major cardiovascular events, death, cognitive function, and disability.
Main Results:
- Early data from 1682 randomized patients show a blood pressure difference of 11.9 mmHg systolic and 3.9 mmHg diastolic between treatment and control groups.
- Six strokes and two non-stroke cardiovascular deaths recorded after 3174 patient-months of follow-up.
- Treatment with perindopril and indapamide was well tolerated.
Conclusions:
- Full recruitment into the PROGRESS study is feasible.
- The observed blood pressure reductions suggest the trial will have sufficient power to achieve its primary objectives.
- Satisfactory treatment compliance and successful recruitment of 6000 patients are crucial for study success.
Objectives:
The primary objective of PROGRESS is to determine reliably the efficacy of lowering blood pressure for the prevention of stroke in 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 enzyme inhibitor perindopril, alone or in combination with the diuretic indapamide.
Methods:
The study population comprises 6000 normotensive or hypertensive patients with a history of stroke or transient ischaemic attack within the previous 5 years. The study is being conducted in over 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 placebo is performed by fax direct to Auckland, New Zealand. The primary study outcome is total stroke and secondary outcomes include fatal or non-fatal stroke, total major cardiovascular events and deaths, cognitive function and disability. Patients will be followed for a minimum of 4 years after randomization.
Results:
By 16 July 1996, 162 local clinical centres had been registered across the seven regions, and 1682 patients, 49% with a history of hypertension, had been randomly assigned to receive active treatment or placebo, with 65% allocated to the combination of perindopril and indapamide or double placebo, and 35% to perindopril alone or single placebo. Three months after randomization, the 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 deaths 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 indapamide is well tolerated in the study population. The blood pressure differences between control and treatment groups recorded so far suggest that the study should have the power to achieve its primary objectives, provided compliance with treatment is satisfactory and 6000 patients are successfully recruited and followed for 4-5 years.