Acute Myocardial InfarctionLAMISNCT00805714
Livalo Acute Myocardial Infarction Study
An observational study of Acute Myocardial Infarction, run by JW Pharmaceutical at 10 sites in South Korea.
Trial summary
Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 1,128 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Apr 2007to Mar 2011
- 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
- The patients who have taken pitavastatin since AMI
Who cannot join
- none
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Cardiac and Vascular Center, Hanseo Hospital
Busan
Departments of Cardiology, Catholic University of Daegu College of Medicine
Daegu
Division of Cardiology, Department of Internal Medicine, School of Medicine, Keimyung University
Daegu
Division of Cardiology, Heart Center, Konyang University
Daejeon
Chonnam National University Hospital
Gwangju
Department of Cardiovascular Medicine, Wonkwang University School of Medicine
Iksan
Gachon University Gil Medical Center
Incheon
Division of Cardiology Cardiac Center, Seoul National University Bundang Hospital
Seongnam
Cardiovascular Center, Korea University Guro Hospital
Seoul
Heart Center, Division of Cardiology, Chung-Ang University Hospital
Seoul
About this study
Official title: A Prospective Clinical Observation Study to Evaluate the Influence of Long Term Treatment of Pitavastatin on the Therapeutic Prognosis and Safety in Acute Myocardial Infarction
Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients.
This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute myocardial infarction | AMI patients who are in need to be treated by statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death/MACE for 1 year after the registration
Measured: 1 year
Secondary outcomes (3)
Achievement of LDL cholesterol target level according to the NCEP ATP III guideline
Measured: 1 year
Abnormal change of lab value including CK etc
Measured: 1 year
Adverse event including myalgia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionMar 2011
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
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Ho Jeong, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805714
- Sponsor's protocol ID
- PTV-KAMI
- Acronym
- LAMIS
- Status last verified
- Mar 2012
- First submitted
- 2 Dec 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Observation Study to Evaluate the Influence of Long Term Treatment of Pitavastatin on the Therapeutic Prognosis and Safety in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00805714
- Acronym / sponsor ID
- LAMIS / PTV-KAMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Dec 2008 (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 are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients.
This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction | – | –AMI patients who are in need to be treated by statins |
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 (1 listed)
- The patients who have taken pitavastatin since AMI
Key exclusion criteria (1 listed)
- none
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
Death/MACE for 1 year after the registration
Time frame: 1 year
3 secondary outcomes
Achievement of LDL cholesterol target level according to the NCEP ATP III guideline
Time frame: 1 year
Abnormal change of lab value including CK etc
Time frame: 1 year
Adverse event including myalgia
Time frame: 1 year
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 30 Mar 2012.
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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.
Myung Ho Jeong principal investigator
Chonnam National University Hospital
10 sites 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 10 sites 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 1 inclusion and 1 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Death/MACE for 1 year after the registration (time frame: 1 year). 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 30 Mar 2012.