Coronary Artery DiseasePhase 4ANTARESNCT03529253
Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
A Phase 4 study testing Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily and Rosuvastatin calcium10mg in people with Coronary Artery Disease and Angina Pectoris, run by Kobe University at 1 site in Japan.
Trial summary
The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily and Rosuvastatin calcium10mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2018to 30 Sep 2020
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who underwent PCI for ACS or stable coronary heart disease
- Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
- Patients who remained 25-75% stenosis with coronary angiography
- Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
- Patients aged ≥20 years old at PCI
- Patients who agree to be enrolled in the trial give signed written informed consent
Who cannot join
- Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
- Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
- Known hypersensitivity to alirocumab or rosuvastatin
- All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
- Known history of hemorrhagic stroke
- Currently under treatment for cancer
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- Patients on lipoprotein apheresis
- Patients with severe liver or renal dysfunction
- Pregnant or breastfeeding women
- Patients recognized as inadequate by attending physician
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
The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.
Read the detailed description
The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily, Rosuvastatin calcium10mg
- Keywords
- Alirocumab, NIRS-IVUS, LCBI
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/dailyDrug
Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.
Rosuvastatin calcium10mgDrug
Rosuvastatin10mg/daily by oral for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Intensive therapy group | Experimental | Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily. Receives: Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily |
| Standard therapy group | Active comparator | The standard therapy group is Rosuvastatin10mg/daily alone. Receives: Drug: Rosuvastatin calcium10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maxLCBI (4mm)
Measured: baseline and 9 months
Secondary outcomes (3)
change amount of LCBI(lesion)
Measured: baseline and 9 months
change amount of Angle of lipid core
Measured: baseline and 9 months
change amount of LDL-Cholesterol level
Measured: baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529253
- Sponsor's protocol ID
- 290068
- Acronym
- ANTARES
- Status last verified
- Aug 2018
- First submitted
- 7 May 2018
- Last updated
- 31 Aug 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
- ClinicalTrials.gov ID
- NCT03529253
- Acronym / sponsor ID
- ANTARES / 290068
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Alirocumab, NIRS-IVUS, LCBI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 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 purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.
Detailed description
The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive therapy group | Experimental | Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/dailyAlirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily. |
| Standard therapy group | Active comparator | Drug: Rosuvastatin calcium10mgThe standard therapy group is Rosuvastatin10mg/daily alone. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who underwent PCI for ACS or stable coronary heart disease
- Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
- Patients who remained 25-75% stenosis with coronary angiography
- Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
- Patients aged ≥20 years old at PCI
Key exclusion criteria (10 listed)
- Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
- Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
- Known hypersensitivity to alirocumab or rosuvastatin
- All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
- Known history of hemorrhagic stroke
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 |
|---|---|---|
| Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/dailyAlirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months. | Drug | Intensive therapy group |
| Rosuvastatin calcium10mgRosuvastatin10mg/daily by oral for 9 months. | Drug | Standard therapy group |
Primary outcome
maxLCBI (4mm)
Time frame: baseline and 9 months
3 secondary outcomes
change amount of LCBI(lesion)
Time frame: baseline and 9 months
change amount of Angle of lipid core
Time frame: baseline and 9 months
change amount of LDL-Cholesterol level
Time frame: baseline and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily and Rosuvastatin calcium10mg in people with Coronary Artery Disease and Angina Pectoris, 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 6 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: status not confirmed, as of the sponsor's last update on 31 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Hiromasa Otake, MD, PhD (078-382-5846, 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?
maxLCBI (4mm) (time frame: baseline and 9 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 31 Aug 2018.