Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound
Phase 4
- Conditions
- patients aged 30-85 years who were undergoing percutaneous coronary intervention (PCI, elective or emergency) with >=1 significant stenosis >=75% and >=1 untouched nonculprit lesion of <=50% stenosis that could be imaged by intravascular ultrasound, and either LDL-C >=100 mg/dl.
- Registration Number
- JPRN-UMIN000002959
- Lead Sponsor
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
- Familial hypercholesterolemia - Being treated with Zetia (Ezetimibe) - Being treated with Fibrates - Renal insufficiency (serum creatinine >= 2.0 mg/dl) - Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase >= 3-folds of standard value in each institute) - Undergoing hemodialysis or peritoneal dialysis - Allergic to Lipitor and/or Zetia - Severe underlying disease - Lack of decision-making capacity - Recognized as inadequate by attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change from baseline (before randomization) to follow-up (9-12 momths after randomization) in the percentage atheroma volume (PAV)
- Secondary Outcome Measures
Name Time Method