Cardiovascular disease Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
Pravastatin 40 mg or matching placebo tablets to be taking orally once per day throughout the period of follow-up. Because of the expected 2-year period of recruitment and variable follow-up, treatmen
Sponsors
Bristol-Myers Squibb Company (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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/L
Exclusion criteria
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] 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 15,000/mm³ 5. Serum creatinine > 200 µmol/L 6. Potassium 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure was the combined endpoint of coronary heart disease (CHD) death (definite plus suspect), nonfatal myocardial infarction (definite plus suspect), and fatal plus nonfatal stroke. Secondary analyses was performed for the primary endpoint in the following subgroups: 1. Men 2. Women 3. Subjects with or without evidence of previous vascular disease defined as stable angina or intermittent claudication; or stroke, transient ischemic attack (TIA), myocardial infarction (MI), arterial surgery, or amputation for vascular disease prior to study entry, but who are considered to be at high risk on the basis of smoking history, diabetes or hypertension. 4. Subjects with previous vascular disease including stable angina or intermittent claudication; or stroke, transient ischemic attack (TIA), myocardial infarction (MI), arterial surgery, or amputation for vascular disease more than 6 months prior to study entry. All analyses were carried out on a time to first event basis with analysis censored at end of follow-up, death from other causes or withdrawal of consent. Outcomes could occur continuously throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatal plus nonfatal stroke 2. Coronary events: definite plus suspect CHD death, definite plus suspect nonfatal MI | — |
Countries
Ireland, Netherlands, Scotland, United Kingdom
Outcome results
None listed