Condition category
Circulatory System
Date applied
15/08/2005
Date assigned
09/09/2005
Last edited
24/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes