Myocardial InfarctionPhase 4NCT00128024
Effects of Early Statin Treatment After Acute Myocardial Infarction (AMI) in Japanese Patients
A Phase 4 study testing lipid-lowering treatment in people with Myocardial Infarction, run by Kumamoto University at 1 site in Japan.
Trial summary
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- lipid-lowering treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2002to Feb 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute myocardial infarction
- Serum total cholesterol levels on admission ranges ≥180 mg/dL and <240 mg/dL
Who cannot join
- Age < 18 years
- Time from symptom onset to admission > 96 hours
- Use of lipid-lowering agents within the previous 3 months
- Known familial dyslipidemia
- Severe renal failure
- Known hepatic disease
Show all 11Show fewer
- Signs and symptoms of severe heart failure (Killip class III or IV)
- A scheduled PCI or coronary artery bypass grafting (CABG)
- A history of previous PCI (within 6 months) or CABG (within 3 months)
- The presence of malignant disease
- The presence of allergy to statins.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
About this study
Official title: Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction. The MUSASHI-AMI: A Multicenter Randomized Controlled Trial
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. The purpose of this study is to determine whether early (within 96 hours after onset) use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients.
Read the detailed description
At least, in Japanese, it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels <240 mg/dL was needed. Furthermore, in general, a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established. Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. A prospective, randomized, open-label, multicenter trial is conducted in AMI patients with normal total cholesterol levels (180-240 mg/dL). Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months. The primary endpoint is a composite of cardiovascular death, nonfatal AMI, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke.
- Conditions
- Myocardial Infarction
- Being tested
- lipid-lowering treatment
- Keywords
- randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid-lowering treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Statins | Active comparator | Not described Receives: Drug: lipid-lowering treatment |
| No statins | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A combination of: cardiovascular death
nonfatal acute myocardial infarction
recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
congestive heart failure requiring emergent rehospitalization
and nonfatal stroke
Secondary outcomes (3)
Reintervention procedures: coronary artery bypass grafting (CABG)
percutaneous coronary intervention (PCI) for a new lesion
and repeat PCI procedures for restenosis of the infarct-related or non-infarct-related lesions (repeat PCI occurring in the first 6 months of follow-up for an index lesion was excluded)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startFeb 2002
- Primary completionFeb 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisao Ogawa, Kumamoto University
- Investigators
- Hisao Ogawa, M.D., Ph.D., Study chair, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128024
- Sponsor's protocol ID
- CVM-RCT-2001-02
- Other IDs
- KUMSEC-2001-035
- Status last verified
- Apr 2013
- First submitted
- 8 Aug 2005
- Last updated
- 18 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction. The MUSASHI-AMI: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00128024
- Acronym / sponsor ID
- CVM-RCT-2001-02
- Conditions
- Myocardial Infarction
- Keywords
- randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 9 Aug 2005 (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.
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. The purpose of this study is to determine whether early (within 96 hours after onset) use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients.
Detailed description
At least, in Japanese, it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels <240 mg/dL was needed. Furthermore, in general, a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established. Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. A prospective, randomized, open-label, multicenter trial is conducted in AMI patients with normal total cholesterol levels (180-240 mg/dL). Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months. The primary endpoint is a composite of cardiovascular death, nonfatal AMI, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statins | Active comparator | Drug: lipid-lowering treatment |
| No statins | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute myocardial infarction
- Serum total cholesterol levels on admission ranges ≥180 mg/dL and <240 mg/dL
Key exclusion criteria (11 listed)
- Age < 18 years
- Time from symptom onset to admission > 96 hours
- Use of lipid-lowering agents within the previous 3 months
- Known familial dyslipidemia
- Severe renal failure
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 |
|---|---|---|
| lipid-lowering treatment | Drug | Statins |
Primary outcome
A combination of: cardiovascular death
nonfatal acute myocardial infarction
recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
congestive heart failure requiring emergent rehospitalization
and nonfatal stroke
3 secondary outcomes
Reintervention procedures: coronary artery bypass grafting (CABG)
percutaneous coronary intervention (PCI) for a new lesion
and repeat PCI procedures for restenosis of the infarct-related or non-infarct-related lesions (repeat PCI occurring in the first 6 months of follow-up for an index lesion was excluded)
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 18 Apr 2013.
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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.
Hisao Ogawa, M.D., Ph.D. study chair
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
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 lipid-lowering treatment in people with Myocardial Infarction, run by Kumamoto University at 1 site in Japan.
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 2 inclusion and 11 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 18 Apr 2013. 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 Japan. 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. 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?
A combination of: cardiovascular death. The study lists 5 primary outcomes in all. 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 18 Apr 2013.