High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study

December 4, 2023 updated by: Hu Bo, Wuhan Union Hospital, China
This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Shengcai Chen, Doctor

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Contact:
          • Shengcai Chen, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old, regardless of sex;
  2. Cerebrovascular angiography examination was performed, and the imaging characteristics were consistent with: 1) The stenosis degree of internal carotid artery (starting from C1 segment) or vertebral artery (starting from vertebral artery to V4 segment) was 20%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;
  3. Participants who understand and sign the informed consent form voluntarily.

Exclusion Criteria:

  1. Intolerant to both atorvastatin and rosuvastatin;
  2. History of major surgery or endovascular treatment within 3 months prior to the screening period;
  3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
  4. Abnormal liver function (ALT > 3 times the upper limit of normal);
  5. Renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73m2 at screening);
  6. Thrombocytopenia (PLT<100G/L);
  7. The expected survival time is not more than 6 months;
  8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;
  9. Patients have been included in other studies that conflict with this study;
  10. Known sensitivity to any of the products or components to be administered during dosing;
  11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;
  12. Other conditions that the investigator considered inappropriate for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Evolocumab treatment group
Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks
Drug: Evolocumab 140 MG/ML
Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times
Active Comparator: Intensive statin treatment group
Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks
Drug: Intensive statin treatment
Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of the thickness of fibrous cap of artery plaque measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the thickness of fibrous cap of artery plaque measured by OCT
27 Weeks ± 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of the minimum lumen area (MLA) measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the minimum lumen area (MLA) measured by OCT
27 Weeks ± 7 days
Changes of lumen area stenosis measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of lumen area stenosis measured by OCT
27 Weeks ± 7 days
Changes of the number of microvessels measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the number of microvessels measured by OCT
27 Weeks ± 7 days
Changes of the presence and extension of macrophages measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the presence and extension of macrophages measured by OCT
27 Weeks ± 7 days
Changes of the calcium aggregation measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the calcium aggregation measured by OCT
27 Weeks ± 7 days
Changes of arterial plaque volume measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by OCT
27 Weeks ± 7 days
Changes of lipid necrotic core of arterial plaque measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of lipid necrotic core of arterial plaque measured by OCT
27 Weeks ± 7 days
Changes of LDL-C levels
Time Frame: 27 Weeks ± 7 days
Changes of LDL-C levels
27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Time Frame: 27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
27 Weeks ± 7 days
Changes of arterial plaque volume measured by 3D-ultrasound
Time Frame: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by 3D-ultrasound
27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Time Frame: 27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Time Frame: 27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
27 Weeks ± 7 days
Changes of arterial plaque volume measured by High resolution magnetic resonance
Time Frame: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by High resolution magnetic resonance
27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Time Frame: 27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
27 Weeks ± 7 days
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Time Frame: 27 Weeks ± 7 days
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
27 Weeks ± 7 days
Changes of the lipid arc of artery plaque measured by OCT
Time Frame: 27 Weeks ± 7 days
Changes of the lipid arc of artery plaque measured by OCT
27 Weeks ± 7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of ischemic vascular events
Time Frame: 27 Weeks ± 7 days
Occurrence of ischemic vascular events, such as TIA, acute cerebral infarction, acute myocardial infarction, etc.
27 Weeks ± 7 days
Adverse events/serious adverse events
Time Frame: through study completion, an average of 6 months
Adverse events/serious adverse events
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Union Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bo Hu, Doctor, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
  • Principal Investigator: Candong Hong, Doctor, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
  • Principal Investigator: Lei Zhang, Doctor, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
  • Principal Investigator: Quanwei He, Doctor, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
  • Principal Investigator: Jiehong Wu, Doctor, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HERALD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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