HypercholesterolemiaLAMISIIINCT04270344
The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment
An observational study of Hypercholesterolemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Pitavastatin 4mg
- How many people
- 905 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2018to 30 Jun 2022
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hypercholesterolemia and AMI
Who may be able to join
- idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
- diagnosed AMI (STEMI, NSTEMI) 1 months ago
- more than 19 years old and more than 2 years of life expectancy at screening
- informed consent
Who cannot join
- cardiogenic shock or corresponding clinical events
- contraindicated to the IP
- unsuitable to this study judged by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
JWP
Seoul, Seocho-gu
KIM HJ, 82-2-840-6802, hjkim@jw-pharma.co.kr
Jeong Myung Ho, Ph.D
About this study
Official title: A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment
Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea
Read the detailed description
Following subjects with AMI event within 1 month will be assessed MACE event for 1year
- Essential hypertension or heart failure
- Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
- Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),
- Conditions
- Hypercholesterolemia
- Being tested
- Pitavastatin 4mg
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin 4mgDrug
Also called valsartan
combination therapy with pitavastatin/valsartan (LivaloV)
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality, non-fatal MI, repeat re-vascularization
MACE
Measured: 12 months
Secondary outcomes (11)
The rate of mortality
MACE
Measured: 6 and 12 months
The rate of cardiac death
MACE
Measured: 6 and 12 months
The rate of nonfatal MI
MACE
Measured: 6 and 12 months
The rate of hospitalization due to heart failure
MACE
Measured: 6 and 12 months
The rate of Coronary artery bypass graft(CABG)
MACE
Measured: 6 and 12 months
The rate of target lesion re-vascularization
MACE
Measured: 6 and 12 months
The rate of target vessel re-vascularization
MACE
Measured: 6 and 12 months
The rate of cerebrovascular disease
MACE
Measured: 6 and 12 months
The change of SBP, DBP
Hypertensive parameters
Measured: 6 and 12 months
The change of TC, TG, HDL-C, LDL-C, hsCRP
Lipid parameters
Measured: 6 and 12 months
The change of HbA1c, FBS
No Onset of Diabetes
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jul 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 905 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myungho Jeong, Professor, Study chair, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270344
- Sponsor's protocol ID
- JW-PTVV-01
- Acronym
- LAMISIII
- Status last verified
- Apr 2021
- First submitted
- 12 Feb 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment
- ClinicalTrials.gov ID
- NCT04270344
- Acronym / sponsor ID
- LAMISIII / JW-PTVV-01
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 905 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Feb 2020 (actual)
- 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.
Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea
Detailed description
Following subjects with AMI event within 1 month will be assessed MACE event for 1year
- Essential hypertension or heart failure
- Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
- Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hypercholesterolemia and AMI
Key inclusion criteria (4 listed)
- idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
- diagnosed AMI (STEMI, NSTEMI) 1 months ago
- more than 19 years old and more than 2 years of life expectancy at screening
- informed consent
Key exclusion criteria (3 listed)
- cardiogenic shock or corresponding clinical events
- contraindicated to the IP
- unsuitable to this study judged by investigators
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 |
|---|---|---|
| Pitavastatin 4mgAlso: valsartancombination therapy with pitavastatin/valsartan (LivaloV) | Drug | – |
Primary outcome
all-cause mortality, non-fatal MI, repeat re-vascularization
Time frame: 12 months
MACE
11 secondary outcomes
The rate of mortality
Time frame: 6 and 12 months
The rate of cardiac death
Time frame: 6 and 12 months
The rate of nonfatal MI
Time frame: 6 and 12 months
The rate of hospitalization due to heart failure
Time frame: 6 and 12 months
The rate of Coronary artery bypass graft(CABG)
Time frame: 6 and 12 months
The rate of target lesion re-vascularization
Time frame: 6 and 12 months
The rate of target vessel re-vascularization
Time frame: 6 and 12 months
The rate of cerebrovascular disease
Time frame: 6 and 12 months
The change of SBP, DBP
Time frame: 6 and 12 months
The change of TC, TG, HDL-C, LDL-C, hsCRP
Time frame: 6 and 12 months
The change of HbA1c, FBS
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Myungho Jeong, Professor study chair
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 Hypercholesterolemia, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myungho Jeong, Professor (82-62-220-6243, myungho@chol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality, non-fatal MI, repeat re-vascularization (time frame: 12 months). 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 13 Apr 2021.