Coronary Artery Disease ProgressionPOLARISNCT03533959
To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy
An observational study of Coronary Artery Disease Progression, run by Kobe University at 1 site in Japan.
Trial summary
The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease Progression
- What is being tested?
- Alirocumab
- How many people
- 31 participants
- Where
- 1 siteJapan
- Study dates
- 18 Dec 2017to Dec 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate. These patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.
Who may be able to join
- The age at the time of consent acquisition is 20 years old or over.
- OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- Document consent has been obtained from the subject person to this research.
Who cannot join
- Patients who have received treatment with PCSK 9 inhibitor in the past
- Patients whose treatment was interrupted before follow-up catheterization during the observation period
- Patients underwent LDL apheresis.
- In the case that the researchers judges it as inappropriate as the object of this research.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, 650-0017
Hiromasa Otake, MD, +81783825846, hotake@med.kobe-u.ac.jp
About this study
Official title: Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.
Read the detailed description
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.
The investigators compare these two group for outcomes.
- Conditions
- Coronary Artery Disease Progression
- Being tested
- Alirocumab
- Keywords
- in-stent neoatherosclerosis, alirocumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
the administration of Alirocumab at least 75mg every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| alirocumab therapy group | patients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks Receives: Drug: Alirocumab | |
| standard statin therapy group | patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid index change between baseline and 9 month follow-up
Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.
Measured: Baseline and 9 month follow-up
Secondary outcomes (1)
Macrophage grade change between baseline and 9 month follow-up
Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° . Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.
Measured: Baseline and 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start18 Dec 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease ProgressionStudies 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
- Investigators
- Hiromasa Otake, M.D., Ph.D, Study chair, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533959
- Sponsor's protocol ID
- KobeU-170179
- Acronym
- POLARIS
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03533959
- Acronym / sponsor ID
- POLARIS / KobeU-170179
- Conditions
- Coronary Artery Disease Progression
- Keywords
- in-stent neoatherosclerosis, alirocumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 May 2018 (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.
The aim of this study is to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis by using optical coherence tomography, in comparison with standard statin therapy.
Detailed description
The investigators investigate to evaluate the efficacy of alirocumab for in-stent neoatherosclerosis. The investigators enrolled the patient who performed drug eluting stent implantation and detected in-stent neoatherosclerosis by follow up optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin the investigatorsre categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group.
The investigators compare these two group for outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alirocumab therapy group | – | Drug: Alirocumabpatients with 10mg daily rosuvastatin and alirocumab at least 75mg every 2 weaks |
| standard statin therapy group | – | –patient with 10mg daily rosuvastatin and never use alirocumab or other PCSK-9 inhibitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stent implantation who were performed coronary angiography and optical coherence tomography (OCT) follow-up of the coronary arteries were candidate. These patients were implanted drug elutingstent including sirolimus-eluting stents (Cypher, Cordis, Miami Lakes, FL, USA), paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA), or everolimus-eluting stents (XIENCE V, Abbott Vascular, Santa Clara, CA, USA). The investigators assessed their OCT examination at the follow-up OCT time and patients who were detected NA on OCT findings were eligible for the presence study.
Key inclusion criteria (5 listed)
- The age at the time of consent acquisition is 20 years old or over.
- OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent
- lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed.
- Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed.
- Document consent has been obtained from the subject person to this research.
Key exclusion criteria (4 listed)
- Patients who have received treatment with PCSK 9 inhibitor in the past
- Patients whose treatment was interrupted before follow-up catheterization during the observation period
- Patients underwent LDL apheresis.
- In the case that the researchers judges it as inappropriate as the object of this research.
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 |
|---|---|---|
| Alirocumabthe administration of Alirocumab at least 75mg every 2 weeks | Drug | alirocumab therapy group |
Primary outcome
Lipid index change between baseline and 9 month follow-up
Time frame: Baseline and 9 month follow-up
Lipid core arc was measured by every 0.2-mm interval throughout segments with neoatherosclerosis (NA) on optical coherence tomography (OCT) findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.
1 secondary outcome
Macrophage grade change between baseline and 9 month follow-up
Time frame: Baseline and 9 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- 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.
Hiromasa Otake, M.D., Ph.D study chair
Kobe University Graduate School of Medicine
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 Coronary Artery Disease Progression, run by Kobe 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 5 inclusion and 4 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 30 May 2018. 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.
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 Hiromasa Otake, M.D., Ph.D (+81-78-382-5111, hotake@med.kobe-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid index change between baseline and 9 month follow-up (time frame: Baseline and 9 month follow-up). 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 May 2018.