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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)

NCT ID: NCT01153334

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-02

Study Completion Date

2013-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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ST-segment Elevation AMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Early intensive rosuvastatin therapy

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Conventional statin therapy

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yangsoo Jang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2009-0277

Identifier Type: -

Identifier Source: org_study_id