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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
  Email 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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