Cerebral AtherosclerosisPhase 4NCT05585151
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
A Phase 4 study testing Evolocumab 140 MG/ML and Intensive statin treatment in people with Cerebral Atherosclerosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Atherosclerosis
- What is being tested?
- Evolocumab 140 MG/ML and Intensive statin treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2022to 1 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of sex;
- 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;
- Participants who understand and sign the informed consent form voluntarily.
Who cannot join
- Intolerant to both atorvastatin and rosuvastatin;
- History of major surgery or endovascular treatment within 3 months prior to the screening period;
- Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
- Abnormal liver function (ALT > 3 times the upper limit of normal);
- Renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73m2 at screening);
- Thrombocytopenia (PLT<100G/L);
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- The expected survival time is not more than 6 months;
- Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;
- Patients have been included in other studies that conflict with this study;
- Known sensitivity to any of the products or components to be administered during dosing;
- Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;
- Other conditions that the investigator considered inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
Shengcai Chen, Doctor contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yan Wan, PHD, +8615872394527, wanyanalan@163.com
Shengcai Chen, PHD
About this study
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.
- Conditions
- Cerebral Atherosclerosis
- Being tested
- Evolocumab 140 MG/ML, Intensive statin treatment
- Keywords
- atherosclerosis, plaque burden, Evolocumab, High-Resolution assessment, OCT
- Medical subject headings
- Intracranial Arteriosclerosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab 140 MG/MLDrug
Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times
Intensive statin treatmentDrug
Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab treatment group | Experimental | Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks Receives: Drug: Evolocumab 140 MG/ML |
| Intensive statin treatment group | Active comparator | Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks Receives: Drug: Intensive statin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the thickness of fibrous cap of artery plaque measured by OCT
Changes of the thickness of fibrous cap of artery plaque measured by OCT
Measured: 27 Weeks ± 7 days
Secondary outcomes (16)
Changes of the lipid arc of artery plaque measured by OCT
Changes of the lipid arc of artery plaque measured by OCT
Measured: 27 Weeks ± 7 days
Changes of the minimum lumen area (MLA) measured by OCT
Changes of the minimum lumen area (MLA) measured by OCT
Measured: 27 Weeks ± 7 days
Changes of lumen area stenosis measured by OCT
Changes of lumen area stenosis measured by OCT
Measured: 27 Weeks ± 7 days
Changes of the number of microvessels measured by OCT
Changes of the number of microvessels measured by OCT
Measured: 27 Weeks ± 7 days
Changes of the presence and extension of macrophages measured by OCT
Changes of the presence and extension of macrophages measured by OCT
Measured: 27 Weeks ± 7 days
Changes of the calcium aggregation measured by OCT
Changes of the calcium aggregation measured by OCT
Measured: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by OCT
Changes of arterial plaque volume measured by OCT
Measured: 27 Weeks ± 7 days
Changes of lipid necrotic core of arterial plaque measured by OCT
Changes of lipid necrotic core of arterial plaque measured by OCT
Measured: 27 Weeks ± 7 days
Changes of LDL-C levels
Changes of LDL-C levels
Measured: 27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Changes of the thickness of minimum fibrous cap of artery plaque measured by 3D-ultrasound
Measured: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by 3D-ultrasound
Changes of arterial plaque volume measured by 3D-ultrasound
Measured: 27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Measured: 27 Weeks ± 7 days
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Changes of the thickness of minimum fibrous cap of artery plaque measured by High resolution magnetic resonance
Measured: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by High resolution magnetic resonance
Changes of arterial plaque volume measured by High resolution magnetic resonance
Measured: 27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Changes of Lipid necrotic core of arterial plaque measured by High resolution magnetic resonance
Measured: 27 Weeks ± 7 days
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Correlation between arterial plaque and new risk factors for cardiovascular and cerebrovascular diseases (serum hsCRP, other markers, etc.)
Measured: 27 Weeks ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start9 Nov 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Bo, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Bo Hu, Doctor, Study chair, Union Hospital, Tongji Medical College, Huahzong University of Science and TechnologyCandong Hong, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huahzong University of Science and TechnologyLei Zhang, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huahzong University of Science and TechnologyQuanwei He, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huahzong University of Science and TechnologyJiehong Wu, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585151
- Sponsor's protocol ID
- HERALD
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
- ClinicalTrials.gov ID
- NCT05585151
- Acronym / sponsor ID
- HERALD
- Conditions
- Cerebral Atherosclerosis
- Keywords
- atherosclerosis, plaque burden, Evolocumab, High-Resolution assessment, OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 18 Oct 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab treatment group | Experimental | Drug: Evolocumab 140 MG/MLEvolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks |
| Intensive statin treatment group | Active comparator | Drug: Intensive statin treatmentAtorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, regardless of sex;
- 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;
- Participants who understand and sign the informed consent form voluntarily.
Key exclusion criteria (12 listed)
- Intolerant to both atorvastatin and rosuvastatin;
- History of major surgery or endovascular treatment within 3 months prior to the screening period;
- Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
- Abnormal liver function (ALT > 3 times the upper limit of normal);
- Renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73m2 at screening);
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 |
|---|---|---|
| Evolocumab 140 MG/MLEvolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times | Drug | Evolocumab treatment group |
| Intensive statin treatmentIntensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks | Drug | Intensive statin treatment group |
Primary outcome
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
16 secondary outcomes
Changes of the lipid arc of artery plaque measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of the minimum lumen area (MLA) measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of lumen area stenosis measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of the number of microvessels measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of the presence and extension of macrophages measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of the calcium aggregation measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of arterial plaque volume measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of lipid necrotic core of arterial plaque measured by OCT
Time frame: 27 Weeks ± 7 days
Changes of LDL-C levels
Time frame: 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 arterial plaque volume measured by 3D-ultrasound
Time frame: 27 Weeks ± 7 days
Changes of Lipid necrotic core of arterial plaque measured by 3D-ultrasound
Time frame: 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 arterial plaque volume 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
Shengcai Chen, Doctor contact
Bo Hu, Doctor study chair
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Candong Hong, Doctor principal investigator
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
Lei Zhang, Doctor principal investigator
Union Hospital, Tongji Medical College, Huahzong University of Science and Technology
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 Evolocumab 140 MG/ML and Intensive statin treatment in people with Cerebral Atherosclerosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 3 inclusion and 12 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 11 Dec 2023. 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 China. 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 Yan Wan, Doctor (+8615872394527, wanyanalan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the thickness of fibrous cap of artery plaque measured by OCT (time frame: 27 Weeks ± 7 days). 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 11 Dec 2023.