- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851769
Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability in Patients With Coronary Artery Disease Assessed by Optical Coherence Tomography
The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 mg/dL) despite stable statin therapy.
Eligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36 ± 2 weeks follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 mg/dL) despite stable statin therapy.
Eligible patients included those who are (I) at least 18 years of age, (II) diagnosed as stable coronary artery disease or acute coronary syndrome during admission (III) undergoing clinically indicated coronary angiography and identified with at least one intermediate lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for 2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide written, informed consent.
The study included a 36-week open-label treatment period (including post-treatment OCT imaging), starting within 4 weeks of baseline coronary angiogram. During the open-label treatment period, patients are randomized to receive either alirocumab or standard-of-care (1:1). The last dose of alirocumab will be given at week 34.
Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. Statin dose escalation or adding concomitant non-statin lipid-lowering therapy would be considered by their responsible physician to achieve an LDL-C target <100 mg/dL. Antithrombotic therapy and other concomitant medications are exclusively decided by the responsible physicians. Follow-up coronary angiograms and OCT imaging analyses of the same vessels will be carried out at the end of treatment period (at week 36 ± 2 weeks, depending on patient availability) in both study arms. Regular medical examination and laboratory tests will be conducted at weeks 4, 12, 24, and 36. All enrolled patients are monitored and evaluated for safety and any other adverse events during the study period.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100029
- Beijing Anzhen Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(I) 18 - 80 years of age, (II) diagnosed as stable coronary artery disease or acute coronary syndrome during admission (III) undergoing clinically indicated coronary angiography and identified with at least one intermediate lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for 2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide written, informed consent.
Exclusion Criteria:
- Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
- received target vessel revascularization
- Known hypersensitivity or have contraindications to any anti-PCSK9 monoclonal antibody or statins
- Unable to receive OCT imaging tests
- Known history of hemorrhagic stroke
- Currently under treatment for cancer
- Baseline triglyceride > 400 mg/dl
- Patients with severe liver or renal dysfunction
- Pregnant or breast-feeding women
- Considered by the investigator as inappropriate for this study for any reason
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: alirocumab plus statin
Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).
|
Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).
Other Names:
coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up
|
Active Comparator: standard statin therapy
Patients in the standard statin arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.
Statin dose escalation or adding concomitant non-statin lipid-lowering therapy could be considered by their responsible physician to achieve an LDL-C target <100 mg/dL.
|
coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up
Patients will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimum fibrous-cap thickness
Time Frame: 36 weeks
|
The primary endpoint of the study is the OCT derived changes in minimum fibrous-cap thickness between baseline and follow-up.
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36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimum lumen area and maximum lipid arc
Time Frame: 36 weeks
|
Secondary endpoints include minimum lumen area between baseline and follow-up, as well as the absolute changes in maximum lipid arc.
|
36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yujie Zhou, MD, Beijing Anzhen Hospital
Publications and helpful links
General Publications
- Gao F, Li YP, Ma XT, Wang ZJ, Shi DM, Zhou YJ. Effect of Alirocumab on Coronary Calcification in Patients With Coronary Artery Disease. Front Cardiovasc Med. 2022 May 6;9:907662. doi: 10.3389/fcvm.2022.907662. eCollection 2022.
- Gao F, Wang ZJ, Ma XT, Shen H, Yang LX, Zhou YJ. Effect of alirocumab on coronary plaque in patients with coronary artery disease assessed by optical coherence tomography. Lipids Health Dis. 2021 Sep 12;20(1):106. doi: 10.1186/s12944-021-01528-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- anzhen201803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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