PROspective Study of Pravastatin in the Elderly at Risk (PROSPER)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 5500

Inclusion Criteria

1. Males or females
2. Aged 70-82 years
3. As diagnosed by the primary care physician, evidence of vascular disease including stable angina or intermittent claudication or stroke, transient ischaemic attack (TIA), myocardial infarction (MI), arterial surgery, or amputation for vascular disease more than 6 months prior to study entry
4. No evidence of previous vascular disease as stated above, but considered to be at high risk for vascular disease on the basis of:
4.1. Current smoking status
4.2. Hypertension, currently receiving drug treatment
4.3. Known diabetes mellitus
4.4. Total cholesterol 4.0 - 9.0 mmol/

Exclusion Criteria

1. Recent stroke, TIA, MI, arterial surgery, or amputation for vascular disease less than 6 months prior to study entry
2. Any surgery requiring overnight hospitalisation (including angioplasty) less than 6 months prior to study entry
3. Poor cognitive function at baseline (Mini Mental Status Examination Score [MMSE] < 24)
4. Physically or mentally unable to attend the clinic for the screening visit
5. Cholesterol: Total cholesterol (TC < 4.0 mmol/L or TC > 9.0 mmol/L), Triglycerides (TG > 6.0 mmol/L)
6. Severe renal impairment (serum creatinine > 200 µmol/L)
7. Significant liver disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 X upper limit of normal for the laboratory)
8. History of malignancy within the past 5 years except localised basal cell carcinoma of the skin
9. Congestive heart failure (New York Heart Association Functional Class III or IV)
10. ECG evidence of atrial fibrillation, atrial flutter, or other significant arrhythmia, or Wolff-Parkinson-White Syndrome (WPW)
11. Significant untreated thyroid disease
12. Organ transplant recipient
13. Current lipid-lowering treatment
14. Previous participation in a clinical trial using an HMG CoA reductase inhibitor
15. Inability to give informed consent
16. Planned long-term travel or emigration within next 3 years
17. Current alcohol or drug abuse
18. Co-habitation with another trial participant
19. Less than 75% or greater than 120% compliance with placebo lead-in medication
20. Receipt of any investigational drugs (including placebo) within 30 days of enrolment
21. Inability to tolerate oral medication or a history of significant malabsorption
22. Any other medical condition which renders the patient unable to complete the study which would interfere with optimal participation in the study or produce significant risk to the patient

Abnormal laboratory findings include:
1. Hemoglobin < 11 g/dl
2. Hematocrit < 33%
3. Platelet count < 100,000/mm³
4. White blood cell count < 3,500/mm³ or > 15,000/mm³
5. Serum creatinine > 200 µmol/L
6. Potassium < 3.0 mmol/L or 5.0 mmol/L
7. Sodium < 130 mmol/L or 150 > mmol/L
8. Aspartate aminotransferase/alanine aminotransferase (AST or ALT) > 3.0 X upper limit of normal for the laboratory
9. Creatine kinase (CK) > 3 times upper limit of normal for the laboratory