Phase 3
Completed N=12,064
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Source: ClinicalTrials.gov NCT00124072 ↗Enrolled (actual)
12,064
Serious AEs
83.4%
Results posted
Jun 2010
Primary outcomePrimary: Major Vascular Events (MVE) — 1553; 1477; 1537; 1493 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Vascular Events (MVE) |
1553; 1477; 1537; 1493 | — |
| SECONDARY MVEs Separately in Year 1 and in Later Years |
— | — |
| SECONDARY MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL) |
— | — |
| SECONDARY MVEs in Presence and Absence of the Other Factorial Treatment |
— | — |
| SECONDARY Major Coronary Events |
— | — |
| SECONDARY Total Strokes |
— | — |
Eligibility Criteria
Inclusion Criteria
- Prior myocardial infarction
- Statin therapy indicated
- No clear indication for folic acid
Exclusion Criteria
- No clear contraindication to study treatments
- Screening plasma total cholesterol <3.5 mmol/l in patient already on statin therapy, or <4.5 mmol/l in patient not on statin therapy
- Chronic liver disease
- Severe renal disease or evidence of renal impairment
- Inflammatory muscle disease
- Concurrent treatment with fibrates or high-dose niacin
- Concurrent treatment with cyclosporin (or condition likely to result in organ transplantation and the need for cyclosporin), nefazodone, methotrexate, systemic azole antifungal or systemic macrolide antibiotics
- Child bearing potential
- No other predominant medical problem (other than coronary heart disease [CHD]) which might limit compliance with 5 years of study treatment
Data sourced from ClinicalTrials.gov (NCT00124072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.