Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01153334
First received: June 29, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 loading and 7 days post PCI and 10 mg daily thereafter) versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10 mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The infarct size in the early high dose rosuvastatin group is smaller than that of the control patients treated with low does conventional statin therapy.


Condition Intervention Phase
ST-segment Elevation AMI
Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Infarct size measured by cardiac MRI [ Time Frame: day 3-7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: July 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early intensive rosuvastatin therapy Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)
1. Test group: Early intensive rosuvastatin therapy - rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter 2. Control group: Conventional statin therapy - Placebo for pre-PCI loading in ER and rosuvastatin 10 mg daily after primary PCI
Placebo Comparator: Conventional statin therapy Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)
1. Test group: Early intensive rosuvastatin therapy - rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter 2. Control group: Conventional statin therapy - Placebo for pre-PCI loading in ER and rosuvastatin 10 mg daily after primary PCI

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male or female over 20 years of age
  3. Signed written informed consent to participate in the study

Exclusion Criteria:

  1. Congestive heart failure (NYHA Class III or IV) or LVEF <35%.
  2. Clinically significant heart disease requiring CABG, cardiac transplantation, surgical repair and/or replacement during the course of the study.
  3. Previous MI or CABG
  4. Known serious or hypersensitivity reactions to statin, antiplatelet agents (aspirin or clopidogrel), or heparin.
  5. Known familial hypercholesterolemia
  6. Known skeletal muscle disease
  7. Known active liver disease such as hepatitis or liver cirrhosis (except for fatty liver)
  8. Renal failure (Cr >2.0 mg/dL)
  9. Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism, and/or nephrotic syndrome
  10. Non-cardiac comorbidity with a life expectation < 1 year
  11. Contraindications to CMRI (eg, implanted pacemaker or cardiac defibrillator, claustrophobia, etc.)
  12. Pregnant or lactating women or women of childbearing potential
  13. Participation in any investigational drug or device study within 30 days prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153334

Contacts
Contact: Yangsoo Jang, M.D, Ph.D 82-2-2228-8460 jangys1212@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yangsoo Jang, MD, Ph.D    82-2-2228-8445    jangys1212@yuhs.ac   
Sponsors and Collaborators
Yonsei University
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Yangsoo Jang, M.D, Ph.D Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01153334     History of Changes
Other Study ID Numbers: 4-2009-0277
Study First Received: June 29, 2010
Last Updated: March 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014