Improve-It
Protocol Number: PO4103
Therapeutic Area: Cardiology
Summary:
Clinical Benefit and Safety of Vytorin vs Simvastatin Monotherapy in High Risk subjects presenting with Acute Coronary Syndrome. Adult subjects admitted with diagnosis of high-risk ACS will be selected for the study
Inclusion Criteria:
- NSTEMI ACS symptoms <10 days of admission
- ≥ 50 years of age
- Any 1 of the following criteria:
- EKG changes (> 1 contiguous leads) by either.
- New or presumably new ST-segment depression > 0.1 mV; or
- Transient (<30 minutes) ST-segment elevation > 0.1 mV.
- Any of the following biomarkers elevated above the upper limit of normal (ULN): Troponin 1; Troponin T; and/or Creatinine kinase-MB fraction (CK-MB)
- Diabetes Mellitus
- History of CABG > 3 years prior to entry
- Multivessel CAD by cath (2-3 vessels, > 50% stenosis)
- EKG changes (> 1 contiguous leads) by either.
- Statin-naïve: (LDL >50, <125) and TriG <350 or Statin-chronic: (LDL>50, <100) and TriG<350
Exclusion Criteria:
- Active Liver disease or Elevate LFT
- Allergy/sensitivity to any statin or ezetimibe
- Receiving chronic statin therapy all doses rosuvastatin (Crestor) or LDL lowering potency > Simvastatin 40 mg
*Additional Eligibility Criteria Exist*
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: rhumphreys@mercymiami.org