Prospective Study of Pravastatin in the Elderly at Risk
The objective of this study was 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.
- Start Year
- 1997
- End Year
- 2002
- Supplementary Information
-
Shepherd J, Blauw GJ, Murphy MB, et al. The design of a prospective study of Pravastatin in the Elderly at Risk (PROSPER). The American journal of cardiology, 1999; 84(10): 1192-7.
| Investigators | Contacts |
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Design
- Study design
- Clinical trial
- Follow Up
-
There were 4 screening assessments, then participants were reviewed every 3 months following the randomization.
- Supplementary Information
-
The PROSPER study was a double-blind, randomized, placebo-controlled trial.
Marker Paper
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.
PUBMED 12457784
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 5,804
- Number of Participants with Biological Samples
- 5,804
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Timeline
Populations
The participants were elderly men and women, aged 70 to 82 years, and living in Scotland, Ireland and the Netherlands. Approximately half of the study population had evidence of vascular disease and the other half were at high risk for vascular disease because of smoking, hypertension or diabetes. At the time of randomization, this group was assigned the pravastatin 40 mg on a double-blind basis.
Selection Criteria
- Minimum age
-
70
- Maximum age
-
82
- Newborns
- Twins
- Countries
-
- Ireland
- Netherlands
- United Kingdom
- Other Criteria
-
At baseline, the participants had to have:
- Plasma total cholesterol of 4.0 to 9.0 mmol/L;
- Triglycerides concentrations less than 6.0 mmol/L;
- Good cognitive function (MMSE score of at least 24);
- Been at least 75% compliant with placebo medication during the placebo lead-in period.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Individuals were identified in the primary care setting during a 10-weeks screening and enrollment program.
Number of Participants
- Number of Participants
- 2,891
- Number of Participants with Biological Samples
- 2,891
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PROSPER - Screening
|
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 ... |
1997-12 | 1999-05 |
| 1 |
PROSPER - Trial
|
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 ... |
1998-02 | 2002-11 |
The participants were elderly men and women, aged 70 to 82 years, and living in Scotland, Ireland and the Netherlands. Approximately half of the study population had evidence of vascular disease and the other half were at high risk for vascular disease because of smoking, hypertension or diabetes. At the time of randomization, this group was assigned the placebo on a double-blind basis.
Selection Criteria
- Minimum age
-
70
- Maximum age
-
82
- Newborns
- Twins
- Countries
-
- Ireland
- Netherlands
- United Kingdom
- Other Criteria
-
At baseline, the participants had to have:
- Plasma total cholesterol of 4.0 to 9.0 mmol/L;
- Triglycerides concentrations less than 6.0 mmol/L;
- Good cognitive function (MMSE score of at least 24);
- Been at least 75% compliant with placebo medication during the placebo lead-in period.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Individuals were identified in the primary care setting during a 10-weeks screening and enrollment program.
Number of Participants
- Number of Participants
- 2,913
- Number of Participants with Biological Samples
- 2,913
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PROSPER - Screening
|
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 ... |
1997-12 | 1999-05 |
| 1 |
PROSPER - Trial
|
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 ... |
1998-02 | 2002-11 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
- Perception of health
- Quality of life
- Life course development
- Functional limitations
- Other perception of health, quality of life and functional limitation-related information
Socio-demographic and economic characteristics
Lifestyle and behaviours
Perception of health, quality of life, development and functional limitations
Diseases
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Administrative information
Cognitive functioning
Functional limitations