Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124072
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2005-07-22
Brief Title:
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
SEARCH Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEARCH
Brief Summary:
SEARCH is a randomised double-blind multi-centre United Kingdom UK trial of 12064 patients with myocardial infarction MI prior to study entry which aims to demonstrate whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid 2 mg vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in vascular disease
Detailed Description:
In observational studies lower blood cholesterol concentrations are associated with lower coronary risk without any clear threshold below which lower levels are not associated with lower risk Cholesterol reduction with statins reduces such risk but there is uncertainty about whether greater reductions with more intensive statin therapy will produce greater benefits Elevated blood homocysteine levels appear to be an independent marker of cardiovascular risk but it is unknown whether taking vitamins to reduce homocysteine concentrations will translate into cardiovascular benefit
12064 survivors of myocardial infarction have been randomised in a 2x2 factorial design to more intensive versus standard cholesterol-lowering treatment using 80 mg or 20 mg daily simvastatin and separately to homocysteine-lowering with folic acid plus vitamin B12 or matching placebo Follow-up will continue until there are at least 2800 confirmed major vascular events MVE defined as non-fatal myocardial infarction coronary death stroke or arterial revascularisation The primary outcome is the incidence of first MVE during the scheduled treatment period
SEARCH should provide reliable evidence of the effectiveness and safety of more intensive cholesterol-lowering for the reduction of major vascular events in a high-risk population and of the effects of homocysteine-lowering with folic acid plus vitamin B12
12064 survivors of myocardial infarction have been randomised in a 2x2 factorial design to more intensive versus standard cholesterol-lowering treatment using 80 mg or 20 mg daily simvastatin and separately to homocysteine-lowering with folic acid plus vitamin B12 or matching placebo Follow-up will continue until there are at least 2800 confirmed major vascular events MVE defined as non-fatal myocardial infarction coronary death stroke or arterial revascularisation The primary outcome is the incidence of first MVE during the scheduled treatment period
SEARCH should provide reliable evidence of the effectiveness and safety of more intensive cholesterol-lowering for the reduction of major vascular events in a high-risk population and of the effects of homocysteine-lowering with folic acid plus vitamin B12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None