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| [ ...Back to search results ] | [ Print-friendly version ] |
| Heart protection study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN48489393 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | G9123430 |
| Public title | Heart protection study |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Coronary heart disease (CHD) |
| Study hypothesis | 1. Providing unequivocal evidence about the effects of cholesterol-lowering drug therapy with simvastatin on total mortality among high-risk patients 2. Demonstrating reliably the effects on coronary heart disease (CHD) within several subgroups where there is still uncertainty (e.g. women, elderly, below-average cholesterol, hypertensive) 3. Providing reliable information about effects on non-cardiac mortality and morbidity (i.e. cancer, trauma, etc.), on vascular surgery and other hospitalisations and any major side-effects 4. Assessing effects of vitamin supplementation on CHD |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/01/1994 |
| Anticipated end date | 01/10/2001 |
| Status of trial | Completed |
| Target number of participants | 20,000 |
| 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 capsules Treatment duration was for five years. |
| Primary outcome measure(s) | 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 outcome measure(s) | Not provided at time of registration |
| Publications | Results in: 1. http://www.ncbi.nlm.nih.gov/pubmed/15771782 2. http://www.ncbi.nlm.nih.gov/pubmed/17239712 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent London United Kingdom W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr Rory Collins |
| Contact details | Clinical Trial Service Unit Radcliffe Infirmary Oxford United Kingdom OX2 6HE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN48489393 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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