Status:
COMPLETED
Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
ST-segment Elevation AMI
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy (rosuvastatin 40 mg for pre-PCI...
Eligibility Criteria
Inclusion
- Patient had the symptoms of acute myocardial infarction within 12 hours with ST-segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
- Male or female over 20 years of age
- Signed written informed consent to participate in the study
Exclusion
- Congestive heart failure (NYHA Class III or IV) or LVEF \<35%.
- Clinically significant heart disease requiring CABG, cardiac transplantation, surgical repair and/or replacement during the course of the study.
- Previous MI or CABG
- Known serious or hypersensitivity reactions to statin, antiplatelet agents (aspirin or clopidogrel), or heparin.
- Known familial hypercholesterolemia
- Known skeletal muscle disease
- Known active liver disease such as hepatitis or liver cirrhosis (except for fatty liver)
- Renal failure (Cr \>2.0 mg/dL)
- Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism, and/or nephrotic syndrome
- Non-cardiac comorbidity with a life expectation \< 1 year
- Contraindications to CMRI (eg, implanted pacemaker or cardiac defibrillator, claustrophobia, etc.)
- Pregnant or lactating women or women of childbearing potential
- Participation in any investigational drug or device study within 30 days prior to study entry
Key Trial Info
Start Date :
August 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2013
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01153334
Start Date
August 2 2010
End Date
June 27 2013
Last Update
November 28 2017
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752