Completed

NCT Number: NCT01153334

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

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.

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Key information

Conditions

ST-segment Elevation AMI

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)

Drug

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

Primary outcomes

Infarct size measured by cardiac MRI

Time frame: day 3-7

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

CardioVascular Research Foundation, Korea

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jun 30, 2010
Registry last updated: Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.