Contact information
Type
Scientific
Primary contact
Prof Rory Collins
ORCID ID
Contact details
Clinical Trial Service Unit
Richard Doll Building
Old Road Campus
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 743743
Secretary@ctsu.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CTSU SEARCH1
Study information
Scientific title
Acronym
SEARCH
Study hypothesis
Do larger reductions in blood cholesterol produce larger, and worthwhile, reductions in cardiovascular risk, and does homocysteine-lowering with folic acid and vitamin B12 reduce cardiovascular risk?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Coronary heart disease
Intervention
Simvastatin 80 mg versus 20 mg daily, and separately folic acid 2 mg plus 1 mg vitamin B12 daily or matching placebo tablets.
Intervention type
Supplement
Phase
Not Specified
Drug names
Simvastatin, folic acid and vitamin B12
Primary outcome measures
Major vascular events (MVEs) during the scheduled treatment period
Secondary outcome measures
MVEs separately during the first year and in the later years of the study, MVEs in patients subdivided by pre-randomisation lipid levels, MVEs in the presence and absence of the other randomised treatments, major coronary events, total strokes
Overall trial start date
30/07/1998
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women who have survivied a heart attack and in whom statin therapy is indicated.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12,064
Participant exclusion criteria
Age under 18 years or over 80 at invitation, contraindications to either study drug, other predominant medical problem.
Recruitment start date
30/07/1998
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Trial Service Unit
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
search@ctsu.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
A grant to Oxford University from Merck and Co.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18650507
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20571015
Publication citations
-
Results
, Link E, Parish S, Armitage J, Bowman L, Heath S, Matsuda F, Gut I, Lathrop M, Collins R, SLCO1B1 variants and statin-induced myopathy--a genomewide study., N. Engl. J. Med., 2008, 359, 8, 789-799, doi: 10.1056/NEJMoa0801936.
-
Results
, Armitage JM, Bowman L, Clarke RJ, Wallendszus K, Bulbulia R, Rahimi K, Haynes R, Parish S, Sleight P, Peto R, Collins R, Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial., JAMA, 2010, 303, 24, 2486-2494, doi: 10.1001/jama.2010.840.