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View of NCT00202878 on 2009_07_15

ClinicalTrials Identifier:NCT00202878
Updated:2009_07_15

Descriptive Information
Brief title

IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103AM3)
Official title

A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief summary

This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg.  If LDL-C response is inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, as appropriate, may be increased to 80 mg.  Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke.
Detailed description

PhasePhase 3
Study typeInterventional
Study designTreatment
Study designRandomized
Study designDouble Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Study designActive Control
Study designParallel Assignment
Study designSafety/Efficacy Study
Primary outcome To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal coronary events (such as heart attack), and non-fatal strokes Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years. Thus, the anticipated completion dates below may be adjusted on the basis of actual event occurrance. No
Secondary outcome To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cause, non-fatal coronary events (such as heart attack), and non-fatal stroke Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years No
Secondary outcome To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on coronary heart disease-related death, non-fatal heart attack, and by-pass surgery Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years No
Secondary outcome To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal heart attack, angina leading to hospitalization, by-pass surgery, and non-fatal stroke Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years No
Condition Hypercholesterolemia
Condition Myocardial Infarction
Arm/Group
Arm Label: ezetimibe/simvastatin         Experimental
Arm/Group
Arm Label: simvastatin         Active Comparator
Intervention
Drug: ezetimibe/simvastatin         Arm Label: ezetimibe/simvastatin

ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)
Intervention
Drug: simvastatin         Arm Label: simvastatin

simvastatin 40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)

Recruitment Information
StatusRecruiting
Start date 2005-10
Last follow-up date 2012-06 (Anticipated)
Primary completion date 2012-06 (Anticipated)
Criteria

Inclusion Criteria:
 - Clinically stable subjects may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either STEMI or Non-STEMI or unstable angina)
 - Subjects not taking a statin must have an LDL-C of 125 mg/dl or less.  Subjects taking a statin must have an LDL-C of 100 mg/dl or less.

Exclusion Criteria:
 - Pregnant or lactating woman, or intending to become pregnant
 - Subject with active liver disease or persistent unexplained serum transaminase elevation
 - History of alcohol or drug abuse
 - History of sensitivity to statin or ezetimibe
 - A subject for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Gender Both
Minimum age18 Years
Healthy volunteersNo

Administrative Data
Organization nameSchering-Plough
Organization study IDP04103
Lead sponsor Schering-Plough
Sponsor Merck
Health Authority United States: Food and Drug Administration