ST-segment Elevation Myocardial InfarctionPhase 2NCT02770664
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
A Phase 2 study testing LC28-0126 Dose A, LC28-0126 Dose B and LC28-0126 Dose C in people with ST-segment Elevation Myocardial Infarction, run by LG Life Sciences at 1 site in South Korea.
Trial summary
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- LC28-0126 Dose A, LC28-0126 Dose B and LC28-0126 Dose C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Aug 2018
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 75
- Within 12 hours after the onset of chest pain
- ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients
- Signed for written informed consent
Who cannot join
- Left Main disease
- Multi-vessel disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyo-Soo Kim, M.D., Ph.D., 82-2-2072-2226
Hyo-Soo Kim, M.D., Ph.D.
About this study
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).
- Being tested
- Placebo, LC28-0126 Dose A, LC28-0126 Dose B, LC28-0126 Dose C
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
LC28-0126 Dose ADrug
LC28-0126 Dose A
LC28-0126 Dose BDrug
LC28-0126 Dose B
LC28-0126 Dose CDrug
LC28-0126 Dose C
| Study group | Role | What they receive |
|---|---|---|
| LC28-0126 Dose A | Experimental | Not described Receives: Drug: LC28-0126 Dose A |
| LC28-0126 Dose B | Experimental | Not described Receives: Drug: LC28-0126 Dose B |
| LC28-0126 Dose C | Experimental | Not described Receives: Drug: LC28-0126 Dose C |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Troponin I for 72 hours post PCI
Measured: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Secondary outcomes (5)
AUC of CK-MB for 72 hours post PCI
Measured: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
AUC of CK for 72 hours post PCI
Measured: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Infarct size assessed by Cardiac MRI
Measured: Day 4, 30
Myocardial function assessed by Cardiac MRI
Measured: Day 4, 30
Myocardial function assessed by Echocardiogram
Measured: Day 4, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770664
- Sponsor's protocol ID
- LG-CYCL004
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
- ClinicalTrials.gov ID
- NCT02770664
- Acronym / sponsor ID
- LG-CYCL004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2018 (estimated)
- First posted
- 12 May 2016 (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.
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LC28-0126 Dose A | Experimental | Drug: LC28-0126 Dose A |
| LC28-0126 Dose B | Experimental | Drug: LC28-0126 Dose B |
| LC28-0126 Dose C | Experimental | Drug: LC28-0126 Dose C |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 and 75
- Within 12 hours after the onset of chest pain
- ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients
- Signed for written informed consent
Key exclusion criteria (2 listed)
- Left Main disease
- Multi-vessel disease
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| LC28-0126 Dose ALC28-0126 Dose A | Drug | LC28-0126 Dose A |
| LC28-0126 Dose BLC28-0126 Dose B | Drug | LC28-0126 Dose B |
| LC28-0126 Dose CLC28-0126 Dose C | Drug | LC28-0126 Dose C |
Primary outcome
AUC of Troponin I for 72 hours post PCI
Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
5 secondary outcomes
AUC of CK-MB for 72 hours post PCI
Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
AUC of CK for 72 hours post PCI
Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Infarct size assessed by Cardiac MRI
Time frame: Day 4, 30
Myocardial function assessed by Cardiac MRI
Time frame: Day 4, 30
Myocardial function assessed by Echocardiogram
Time frame: Day 4, 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LC28-0126 Dose A, LC28-0126 Dose B and LC28-0126 Dose C in people with ST-segment Elevation Myocardial Infarction, run by LG Life Sciences 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 2 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 12 May 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of Troponin I for 72 hours post PCI (time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h). 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 12 May 2016.