Heart protection study
| ISRCTN | ISRCTN48489393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48489393 |
| Secondary identifying numbers | G9123430 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 30/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Rory Collins
Scientific
Scientific
Clinical Trial Service Unit
Radcliffe Infirmary
Oxford
OX2 6HE
United Kingdom
Study information
| Study design | Randomised placebo controlled factorial design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| 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 |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Coronary heart disease (CHD) |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | Not provided at time of registration |
| Overall study start date | 01/01/1994 |
| Overall study end date | 01/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20,000 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/01/1994 |
| Recruitment end date | 01/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Trial Service Unit
Oxford
OX2 6HE
United Kingdom
OX2 6HE
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/03/2005 | Yes | No | |
| Results article | results | 23/01/2007 | Yes | No | |
| Results article | results | 31/03/2009 | Yes | No | |
| Results article | genetic variant results | 01/02/2011 | Yes | No | |
| Results article | results | 05/02/2011 | Yes | No | |
| Results article | results | 17/05/2011 | Yes | No | |
| Results article | results | 22/05/2012 | Yes | No | |
| Results article | sub-study results on cholesterol and risk of vascular events | 22/05/2012 | Yes | No |
