Coronary heart disease (CHD) Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
Patients were randomised in a 2 x 2 factorial design to receive:
1. 40 mg simvastatin daily or matching placebo tablets
2. Antioxidant vitamins (vitamins E, C and beta-carotene) or matching placebo c
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients at high risk of CHD (e.g., because of history of vascular disease or diabetes) 2. Without clear indication for or contra-indication to statin 3. Male and female adults 4. Non-fasting blood total cholesterol concentrations of at least 3.5 mmol/L (135 mg/dL)
Exclusion criteria
Exclusion criteria: 1. The patient's doctor considered statin therapy to be clearly indicated or contra-indicated 2. A past history of: stroke, myocardial infarction or angina hospitalisation within the previous six months 3. Chronic liver disease or evidence of abnormal liver function 4. Severe renal disease or evidence of substantially impaired renal function 5. Inflammatory muscle disease or evidence of muscle problems 6. Concurrent treatment with cyclosporin, fibrates or high-dose niacin 7. Child-bearing potential 8. Severe heart failure 9. Life-threatening conditions other than vascular disease or diabetes (including any cancer except non-melanoma skin cancer) 10. Any other condition that might limit long-term compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total mortality and cause-specific mortality for statin comparison 2. Total CHD and fatal CHD for vitamin comparison 3. Major vascular events and total CHD for subgroups | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed