|Study of the benefit and safety of a combination of ezetimibe/simvastatin (Vytorin) versus simvastatin alone in high risk patients with acute coronary syndrome (heart attack or angina attack). |
|A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin) vs. Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)[P04103, Amendment #5, dated 6/22/2011 ]|
|Gene Chang, MD|
Why is this study being done?
|The purpose of this study is to compare two drugs, Ezetimibe/Simvastatin Combination 10/40mg (sold as Vytorinâ) and Simvastatin 40mg (sold as Zocorâ). We want to see how well each of these drugs can lower LDL-C (“bad” cholesterol) levels. In addition we want to compare the two drugs to see if one is better than the other in preventing heart attacks, angina attacks, or stroke. Both Vytorinâ and Zocorâ are already approved by the US Food and Drug Administration (FDA) for lowering cholesterol levels in the blood.|
Who is eligible to participate in this study?
|Subjects with NSTE-ACS enrolling directly into the current study:
Clinically stable high-risk NSTE-ACS subjects not participating in the EARLY-ACS Study, who qualify in accordance with the entry criteria of the current Protocol No. P04103 may be eligible to enroll in the current study.
Subjects with STEMI:
Clinically stable subjects with ST segment elevation myocardial infarction (STEMI) may be eligible to enroll in the current study.|
- Subject who is clinically unstable. A subject is considered clinically unstable if he/she displays any of the following spontaneous events for 24 hours prior to Screening/Randomization:
- Hemodynamic events:
- Pulmonary edema/CHF;
- Acute mitral regurgitation;
- Acute ventricular septal defect.
- Ischemic events:
- Recurrent symptoms of cardiac ischemia.
- Arrhythmic events:
- Ventricular fibrillation;
- Sustained ventricular tachycardia;
- Complete heart block;
- High grade second degree heart block.
- Subject requires the following concomitant medications: cyclosporine, diltiazem, danazol, amiodarone, verapamil, niacin, fibrates as concomitant medications or any of the potent CYP3A4 inhibitors itraconazole, ketoconazole, erythromycin, clarithromycin, and telithromycin, HIV protease inhibitors, nefazodone. Short-term therapy of antifungal or antibiotics is acceptable, provided study medication is interrupted during the administration and restarted after short-term therapy is completed.
- Subject is a pregnant or lactating woman, or woman intending to become pregnant.
- Subject has active liver disease or persistent unexplained serum transaminase elevations (≥2 x ULN).
- Subject has a history of alcohol and/or drug abuse.
- Subject has an allergy/sensitivity to any statin, ezetimibe, and/or their excipients.
- The investigator feels that discontinuation of existing lipid-lowering regimen poses a risk to the subject.
- Subject is receiving statin therapy with LDL-C lowering potency greater than simvastatin 40 mg (eg, atorvastatin 40–80 mg, all doses of rosuvastatin, and all doses of Ezetimibe/Simvastatin Combination).
- Subject with prior enrollment in this current study under Protocol No. P04103.
What is involved with this study?
|At the first visit, the following procedures will be done: review of all current medications, review of medical history, vital signs (including blood pressure, pulse, weight, and height) will be checked, full physical examination, and measurement of the waist with a measuring tape. About 4 tablespoons of blood will be drawn from a vein in the forearm for laboratory tests related to the study. Blood tests include cholesterol, LDL-C, total blood counts, blood chemistry, proteins, and blood pregnancy (only for women who can become pregnant). Pregnant women may not take part in this research study.|
How long will this study run?
|Minimum: 48 months; Maximum: 60 months. Duration of treatment is anticipated to be a minimum of 2.5 years.|
Who can I contact for additional information on this trial?
|Susanne E. Donovan, RN, MS