Screening: 1997 – 1999
Trial: 1998 – 2002
There were 4 screening assessments, then participants were reviewed every 3 months following the randomization.
70-82 (clinic patients)
70-82 (clinic patients)
The PROSPER study was a double-blind, randomized, placebo-controlled trial.
Individuals were identified during a 10-weeks screening and enrollment program.
The initial screening visit, conducted by a study nurse, included the consent for the screening process, a brief medical history and recording of vital signs, and dietary and health advices. Data recorded included standard risk factors such as sex, age, blood pressure, heart rate, body mass index, history of hypertension, diabetes, smoking, and vascular disease.
Participants who continued to be eligible were invited to a second screening visit, at which the same data as the first visit were recorded again along with alcohol consumption, current medication use, details of previous major illnesses and ongoing chronic conditions, and a more detailed medical history. A fasting venous blood sample was drawn for biochemical and hematological checks and lipoprotein quantification.
At the third screening visit, another blood sample was taken, and the Mini-Mental State Examination and various psychometric tests (Picture-Word Learning Test, Stroop Word Colour Test, Letter Digit Coding Test) were administered. An ECG reading was also performed. Participants then entered a 4-weeks single-blind placebo lead-in period.
Participants with a compliance to the placebo lead-in period between 75% and 120% were invited to the fourth screening visit, at which time the psychometric tests were re-administered as well as the Activities of Daily Living and Instrumental Activities of Daily Living questionnaires. The study investigator then conducted a medical examination.
Participants were reviewed every 3 months.
Compliance with the study medication was re-checked by pill counting, participants were counseled on healthy eating, details of any adverse events were recorded and concomitant medication was noted. Blood pressure, weight and vital signs were also recorded and a fasting venous blood sample was drawn for lipid and lipoprotein profiling, biochemistry and hematology safety checks.
At yearly inntervals, repeat tests of lipid and lipoprotein profiles, 12-lead electrocardiogram, and cognitive function and disability assessments were performed.
Questionnaires, cognitive measures, physical measures, biosamples (blood)
To examine the hypothesis that pravastatin, at a dose of 40 mg/day, would reduce the risk of cardiovascular and cerebrovascular events in elderly subjects with vascular disease or at high risk of developing vascular disease.
Leiden University Medical Center
Prof. Wouter Jukema
Shepherd J, Blauw GJ, Murphy MB, et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet, 2002; 360(9346): 1623-30.