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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01153334

Enrollment

125

Registered

2010-06-30

Start date

2010-08-02

Completion date

2013-06-27

Last updated

2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-segment Elevation AMI

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.

Interventions

DRUGEarly 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Infarct size measured by cardiac MRI	day 3-7

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026