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IMPROVE-IT

Unstable angina

Objective

Status

Enrollment complete

Condition

Unstable angina

Description

People with a history of Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS) may also have a higher level of Low-Density Lipoprotein Cholesterol "bad" cholesterol (called LDL-C) in their blood. Having all these conditions together increases the chances of having another heart attack, or to have chest pain that gets worse or comes more often. This condition is called "unstable angina".

Purpose

Compare two drugs, Ezetimibe/Simvastatin Combination 10/40 mg (sold as Vytorin®) and Simvastatin 40 mg (sold as Zocor®) to determine how well each of these drugs can lower LDL-C ("bad" cholesterol) levels.

Phase

III

Key Inclusion Criteria

    • Clinically stable persons 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.

Key Exclusion Criteria

  • Pregnant or lactating woman, or intending to become pregnant
  • Persons with active liver disease or persistent unexplained serum transaminase elevation
  • History of alcohol or drug abuse
  • History of sensitivity to statin or ezetimibe
  • A person for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk. 

ClinicalTrials.gov Identifier

NCT00202878

IRB Protocol Number
P04103
Principal Investigator(s)
Rabeea Aboufakher, MD

Clinical Trial Categories

  • Interventional Cardiology
Sponsor(s)
Schering-Plough Pharmaceuticals & Merck & Company
Contact
Brenda Westacott, CCRC at 701-780-1845
or bwestacott@altru.org