CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,064 enrolled
Drug / intervention
Simvastatin 20 mg daily +3 moredrug
Likely dose
Simvastatin 20 mg or 80 mg orally once daily; folic acid 2 mg + vitamin B12 1 mg orally once dailyAI-extracted
Key inclusion· 3
  • History of myocardial infarction
  • Statin therapy indicated (either currently on statin or requires initiation)
  • No clear indication for folic acid supplementation
Key exclusion· 8
  • Plasma total cholesterol already <3.5 mmol/l in patients on statin therapy, or <4.5 mmol/l in statin-naive patients
  • Chronic liver disease
  • Severe renal disease or evidence of renal impairment
  • Inflammatory muscle disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00124072
NCT00124072Phase 3Completed

SEARCH: Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine

University of Oxford·interventional·Posted Jul 26, 2005·Updated Feb 1, 2012

In Brief

A Phase 3 clinical trial evaluating Simvastatin 20 mg daily, Folic acid 2 mg + vitamin B12 1 mg daily, and 2 other interventions for Cardiovascular Disease. Completed, enrolled 12,064 participants across 1 site.

Detailed Summary

SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2005
Enrollment StartJul 1, 1998
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 20.9 years ago

Interventions

Simvastatin 20 mg dailydrug

Simvastatin 20 mg tablet once daily

Folic acid 2 mg + vitamin B12 1 mg dailydietary

Folic acid 2 mg + vitamin B12 1 mg tablet once daily

Simvastatin 80 mg dailydrug

Simvastatin 80 mg tablet once daily

Placebodrug

Placebo vitamin B12/folic acid tablet once daily