At a glance
ClinicalIndex Comparison Record- ✓Clinically stable within 10 days after hospital admission for acute coronary syndrome (STEMI, non-STEMI, or unstable angina)
- ✓LDL-C ≤125 mg/dL if not currently taking a statin
- ✓LDL-C ≤100 mg/dL if currently taking a statin
- ✕Pregnant or lactating or intending to become pregnant
- ✕Active liver disease or unexplained persistent serum transaminase elevation
- ✕History of alcohol or drug abuse
- ✕Known sensitivity or allergy to statin or ezetimibe
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating ezetimibe/simvastatin, simvastatin, and 2 other interventions for Hypercholesterolemia and Myocardial Infarction. Completed, enrolled 18,144 participants.
Detailed 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. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.
Study Details
Timeline
Interventions
Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).
one or two tablets orally daily
one tablet orally daily.