Heart protection study

ISRCTN	ISRCTN48489393
DOI	https://doi.org/10.1186/ISRCTN48489393
Protocol serial number	G9123430
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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 of protocol

Not provided at time of registration

Contact information

Dr Rory Collins
Scientific

Clinical Trial Service Unit
Radcliffe Infirmary
Oxford
OX2 6HE
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled factorial design trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20000
Key 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)
Key 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
Date of first enrolment	01/01/1994
Date of final enrolment	01/10/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Clinical Trial Service Unit

Oxford
OX2 6HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes