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

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ClinicalTrials.gov Identifier: NCT01153334
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : August 2, 2010
Primary Completion Date : June 27, 2013
Study Completion Date : June 27, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Infarct size measured by cardiac MRI [ Time Frame: day 3-7 ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153334


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01153334     History of Changes
Other Study ID Numbers: 4-2009-0277
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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