Heart protection study

Completed

Conditions: Coronary heart disease (CHD)
Circulatory System
Chronic ischaemic heart disease

Registration Number: ISRCTN48489393

Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20000

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Total mortality and cause-specific mortality for statin comparison<br>2. Total CHD and fatal CHD for vitamin comparison<br>3. Major vascular events and total CHD for subgroups

Secondary Outcome Measures