Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine

ISRCTN	ISRCTN74348595
DOI	https://doi.org/10.1186/ISRCTN74348595
ClinicalTrials.gov number	NCT00124072
Secondary identifying numbers	CTSU SEARCH1

Submission date: 15/08/2005
Registration date: 09/09/2005
Last edited: 31/08/2022

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

Prof Rory Collins
Scientific

Clinical Trial Service Unit
Richard Doll Building
Old Road Campus
Oxford
OX3 7LF
United Kingdom

Phone	+44 (0)1865 743743
Email	Secretary@ctsu.ox.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Study acronym	SEARCH
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/07/1998
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12,064
Total final enrolment	12064
Key inclusion criteria	Men and women who have survivied a heart attack and in whom statin therapy is indicated.
Key exclusion criteria	Age under 18 years or over 80 at invitation, contraindications to either study drug, other predominant medical problem.
Date of first enrolment	30/07/1998
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trial Service Unit

Oxford
OX3 7LF
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 270000
Email	search@ctsu.ox.ac.uk
Website	http://www.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Industry

A grant to Oxford University from Merck and Co.

No information available

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/08/2008		Yes	No
Results article	results	23/06/2010		Yes	No
Basic results			26/09/2019	No	No

Editorial Notes

31/08/2022: A long-term follow-up study of SEARCH has been registered as ISRCTN14416153.
26/09/2019: The following changes were made to the trial record:
1. Added ClinicalTrials.gov link to basic results (scientific).
2. The total final enrollment was added.
3. ClinicalTrials.gov number added.