Acute Myocardial InfarctionNCT01265706
Livalo Acute Myocardial Infarction Study (LAMIS)
An observational study of Acute Myocardial Infarction, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AMI patients who are in need to be treated by statins
Who may be able to join
- Patients with STEMI, NSTEMI
- Patients satisfying at least one of the followings
- Patients with LDL-C ≥ 130 mg/dL
- Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator
- Patients taking statin are required continuous cholesterol lowering therapy
- Patients satisfying at least two of the followings
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- The change of Ischemic ECG
- CK, CK-MB, Troponin-I increased more than two times
- The symptom of ACS
Who cannot join
- Patients with in-stent restenosis after PCI or coronary artery bypass
- Patients with cardiogenic shock
- Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)
- Patients who are taking cyclosporine
- Patients who experienced hypersensitivity to pitavastatin
- Patients under dialysis treatment
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- Patients who are participating other clinical trials
- Patients who can not stop taking concomitant drugs
- Pregnant or lactating women or suspected pregnancy
- Patients who are regarded as ineligible for this study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)
This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TLR-MACE for 1 year after enrollment
Measured: 1 year after enrollment
Secondary outcomes (1)
Incidence of TVR-MACE for 1 year after enrollment
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Jun Hong, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265706
- Sponsor's protocol ID
- PTV_LAMIS II
- Status last verified
- Dec 2014
- First submitted
- 18 Oct 2010
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)
- ClinicalTrials.gov ID
- NCT01265706
- Acronym / sponsor ID
- PTV_LAMIS II
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Dec 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.
This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AMI patients who are in need to be treated by statins
Key inclusion criteria (9 listed)
- Patients with STEMI, NSTEMI
- Patients satisfying at least one of the followings
- Patients satisfying at least two of the followings
Key exclusion criteria (10 listed)
- Patients with in-stent restenosis after PCI or coronary artery bypass
- Patients with cardiogenic shock
- Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)
- Patients who are taking cyclosporine
- Patients who experienced hypersensitivity to pitavastatin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of TLR-MACE for 1 year after enrollment
Time frame: 1 year after enrollment
1 secondary outcome
Incidence of TVR-MACE for 1 year after enrollment
Time frame: 1 year after enrollment
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 15 Dec 2014.
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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.
Young Jun Hong principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by JW Pharmaceutical 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 9 inclusion and 10 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 15 Dec 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Incidence of TLR-MACE for 1 year after enrollment (time frame: 1 year after enrollment). 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 15 Dec 2014.