IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
Condition: Hypercholesterolemia; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Hypercholesterolemia; Infarction
Intervention: ezetimibe/simvastatin; simvastatin; Placebo for simvastatin 40 mg; Placebo for ezetimibe 10 mg/simvastatin 40 mg combination
Intervention description: 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.
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 18144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypercholesterolemia; myocardial infarction; cholesterol; randomized controlled trials; acute coronary syndrome; angina

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically stable participants may be eligible to enroll within 10 days following
             hospital admission with high-risk acute coronary syndrome (either ST-elevation
             myocardial infarction [STEMI] or Non-STEMI or unstable angina)

          -  Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants
             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

          -  Participant with active liver disease or persistent unexplained serum transaminase
             elevation

          -  History of alcohol or drug abuse

          -  History of sensitivity to statin or ezetimibe

          -  A participant for whom discontinuation of existing lipid lowering regimen poses an
             unacceptable risk.