Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
| ISRCTN | ISRCTN74348595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74348595 |
| ClinicalTrials.gov (NCT) | NCT00124072 |
| Protocol serial number | CTSU SEARCH1 |
| Sponsor | University of Oxford (UK) |
| Funder | A grant to Oxford University from Merck and Co. |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Clinical Trial Service Unit
Richard Doll Building
Old Road Campus
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)1865 743743 |
|---|---|
| Secretary@ctsu.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Major vascular events (MVEs) during the scheduled treatment period |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 12064 |
| 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
- United Kingdom
- England
Study participating centre
OX3 7LF
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 | 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.
