Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Folic Acid; Hydroxocobalamin; Simvastatin; Vitamin B 12; Vitamin B Complex; Vitamins

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