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21 March 2013
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| [ Print-friendly version ] |
| Heart protection study |
| ISRCTN | ISRCTN48489393 |
| DOI | 10.1186/ISRCTN48489393 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Heart protection study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | G9123430 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised placebo controlled factorial design trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Coronary heart disease (CHD) |
| 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 |
| Anticipated start date | 01/01/1994 |
| Anticipated end date | 01/10/2001 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications |
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15771782
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17239712 3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19442259 4. 2010 genetic variant results in http://www.ncbi.nlm.nih.gov/pubmed/21252144 5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21277016 6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21458191 7. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22539783 8. 2012 sub-study results on cholesterol and risk of vascular events in http://www.ncbi.nlm.nih.gov/pubmed/22539783 |
| Contact name | Dr Rory Collins |
| Address |
Clinical Trial Service Unit
Radcliffe Infirmary |
| City/town | Oxford |
| Zip/Postcode | OX2 6HE |
| Country | United Kingdom |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 06/04/2000 |
| Last edited | 30/07/2012 |
| Date ISRCTN assigned | 06/04/2000 |
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