IMPROVE IT
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
|
Status:
This study is currently recruiting participants.
Purpose:
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.
Interventions:
Ezetimibe
Ezetimibe (pronounced /ɛˈzɛtəmɪb/) is an anti-hyperlipidemic medication which is used to lower cholesterol levels. It acts by decreasing cholesterol absorption in the intestine. It may be used alone when other cholesterol-lowering medications are not tolerated, or together with statins (e.g. ezetimibe/simvastatin, marketed as Vytorin and Inegy) when cholesterol levels are unable to be controlled on statins alone.
|
Simvastatin
HMG-CoA reductase inhibitor; lowers cholesterol
|
Location(s):
Massachusetts
Year Started:
2005
Design:
Interventional, Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study.
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 s 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; subject with a history of alcohol or drug abuse; subject with a history of sensitivity to statin or ezetimibe; subject for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Patient Involvement:
Patients will be randomized to either 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) or 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). Patient will also need to be followed with blood tests during study to determine response to drug.
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.
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; 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; 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.
Source of Information:
ClinicalTrials.gov
|
|
Web Links and Publications:
|
|
This information last updated on: 3/3/2009
Reviewed on: 09/02/2009.
|
Trials
Directories