ST-segment Elevation AMIPhase 4NCT01153334
Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)
A Phase 4 study testing Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) in people with ST-segment Elevation AMI, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ST-segment Elevation AMI
- What is being tested?
- Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2010to 27 Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- ST-segment Elevation AMI
- Being tested
- Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Early intensive rosuvastatin therapy | Experimental | Not described Receives: Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) |
| Conventional statin therapy | Placebo comparator | Not described Receives: Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size measured by cardiac MRI
Measured: day 3-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study start2 Aug 2010
- Primary completion27 Jun 2013
- Study completion27 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation AMIStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor
- Investigators
- Yangsoo Jang, M.D, Ph.D, Principal investigator, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153334
- Sponsor's protocol ID
- 4-2009-0277
- Status last verified
- Nov 2017
- First submitted
- 29 Jun 2010
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)
- ClinicalTrials.gov ID
- NCT01153334
- Acronym / sponsor ID
- 4-2009-0277
- Conditions
- ST-segment Elevation AMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 2 Aug 2010 (actual)
- Primary completion
- 27 Jun 2013 (actual)
- Study completion
- 27 Jun 2013 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intensive rosuvastatin therapy | Experimental | Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) |
| Conventional statin therapy | Placebo comparator | Drug: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Conventional statin therapy, Early intensive rosuvastatin therapy |
Primary outcome
Infarct size measured by cardiac MRI
Time frame: day 3-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangsoo Jang, M.D, Ph.D principal investigator
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) in people with ST-segment Elevation AMI, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size measured by cardiac MRI (time frame: day 3-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.