Carotid Artery StenosisTRIP-CASNCT07036991
A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis, run by Changhai Hospital at 1 site in China.
Trial summary
A multicenter cohort study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe and Rosuvastatin/Atorvastatin ± Ezetimibe
- Type of treatment
- Injection or infusion
- How many people
- 406 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 1 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: For patients with mild to moderate carotid artery stenosis, those who are confirmed to meet the clinical inclusion and exclusion criteria and whose carotid artery plaque burden rate is confirmed to be ≥ 30% through carotid artery ultrasound examination can be registered.
Who may be able to join
- Clinical inclusion criteria:
- Age ≥ 18 years.
- Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.
- Modified Rankin Scale (mRS) score ≤ 2
- Signed informed consent form obtained from the subject
- Ultrasound Inclusion Criteria:
- Carotid ultrasound showing a plaque burden rate ≥30% at the most stenotic cross-sectional site of the carotid artery (common carotid artery or proximal C1 segment of the internal carotid artery).
Who cannot join
- Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.
- Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus/vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic/paroxysmal atrial fibrillation. (Confound ASCVD outcome assessment.)
- History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.
- History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.
- Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
- History of thromboembolic diseases (pulmonary embolism, mesenteric embolism, lower limb arterial embolism) or coronary atherosclerotic heart disease.
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- Severe neurological deficits impairing independent living; diagnosed dementia/psychiatric disorders interfering with follow-up; or life expectancy <3 years due to other conditions.
- Severe/unstable comorbidities: Severe heart failure (NYHA Class III/IV or LVEF <30%), Renal failure (serum creatinine >264 μmol/L or creatinine clearance <0.6 mL/s), Severe hepatic dysfunction (ALT/AST >3× upper limit of normal), CK >5× upper limit of normal, Active malignancy.
- Use of PCSK9 inhibitors or CETP inhibitors within 24 weeks before enrollment.
- The subjects have taken strong inhibitor drugs of cytochrome P-450 3A4 (including: adagrasib, atazanavir, ceritinib, clarithromycin, darunavir, idelalisib, indinavir, itraconazole, ketoconazole, levonorgestrel, lonafarnib, lopinavir, mifepristone, nefazodone, nelfinavir, nirmatrelvir/ritonavir, Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets), mbitasvir/paritaprevir/ritonavir and dasabuvir, posaconazole, co-formulations containing ritonavir and ritonavir itself, saquinavir, erythromycin, tucatinib, voriconazole) within one month before randomization, or may require such drugs during the study period.
- Pregnancy or lactation.
- Concurrent participation in another trial that may affect outcome assessment.
- Other situations that the investigator believes may cause significant harm to the subjects if they participate in this trial.
- Situations where the investigator believes there are other vascular lesions that may lead to short - term ischemic events and surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai
Qiang Li, MD, PhD, +86-13818803656, lqeimm@126.com
About this study
Official title: A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis (TRIP-CAS)
A multicenter cohort study
Read the detailed description
The trial is to evaluate the effect of ultra-intensive lipid-lowering therapy (PCSK9 inhibitor + rosuvastatin or atorvastatin, with/without ezetimibe) versus conventional lipid-lowering therapy (rosuvastatin or atorvastatin, with/without ezetimibe) on changes in atherosclerotic burden in patients with carotid artery stenosis.
- Conditions
- Carotid Artery Stenosis
- Being tested
- PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe, Rosuvastatin/Atorvastatin ± Ezetimibe
- Keywords
- CAS, Carotid Artery Stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± EzetimibeDrug
PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe
Rosuvastatin/Atorvastatin ± EzetimibeDrug
Rosuvastatin/atorvastatin ± ezetimibe
| Study group | Role | What they receive |
|---|---|---|
| Exposure Group: PCSK9 Inhibitor + Statin ± Ezetimibe Group | PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day Receives: Drug: PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe | |
| Non-exposed Group: Statin ± Ezetimibe Group | Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day Receives: Drug: Rosuvastatin/Atorvastatin ± Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque burden rate at the most stenotic carotid site at 180±7 days
Measured: 180±7 days
Secondary outcomes (10)
Lipid profile (TG/TC/LDL-C/HDL-C), liver function (ALT, AST), CK at 30±3 days
Measured: 30±3 days
Lipid profile: TG/TC/LDL-C/HDL-C; liver function: ALT, AST, CK at 180±7 days
Measured: 180±7 days
Plaque burden rate at the most stenotic cross-sectional site of the carotid artery at 180±7 days
Measured: 180±7 days
Plaque diameter stenosis at 180±7 days
Measured: 180±7 days
Plaque dimensions (length × thickness) at 180±7 days
Measured: 180±7 days
Plaque stability (hypoechoic regions, fibrous cap integrity, ulceration, plaque score) at 180±7 days
Measured: 180±7 days
mRS score at 180±7 days
Measured: 180±7 days
Time to first major vascular event within 180±7 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)
Measured: within 180±7 days
mRS score at 365±30 days
Measured: 365±30 days
Time to first major vascular event within 365±30 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)
Measured: within 365±30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start5 Sep 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- 406 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai HospitalPinjing Hui, MD, PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036991
- Sponsor's protocol ID
- TRIP-CAS
- Acronym
- TRIP-CAS
- Status last verified
- Jul 2026
- First submitted
- 29 May 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers need to submit a formal data sharing application to the TRIP-CAS Steering Committee and obtain the approval of the Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis (TRIP-CAS)
- ClinicalTrials.gov ID
- NCT07036991
- Acronym / sponsor ID
- TRIP-CAS / TRIP-CAS
- Conditions
- Carotid Artery Stenosis
- Keywords
- CAS, Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
A multicenter cohort study
Detailed description
The trial is to evaluate the effect of ultra-intensive lipid-lowering therapy (PCSK9 inhibitor + rosuvastatin or atorvastatin, with/without ezetimibe) versus conventional lipid-lowering therapy (rosuvastatin or atorvastatin, with/without ezetimibe) on changes in atherosclerotic burden in patients with carotid artery stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group: PCSK9 Inhibitor + Statin ± Ezetimibe Group | – | Drug: PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± EzetimibePCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day |
| Non-exposed Group: Statin ± Ezetimibe Group | – | Drug: Rosuvastatin/Atorvastatin ± EzetimibeRosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For patients with mild to moderate carotid artery stenosis, those who are confirmed to meet the clinical inclusion and exclusion criteria and whose carotid artery plaque burden rate is confirmed to be ≥ 30% through carotid artery ultrasound examination can be registered.
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Asymptomatic mild-to-moderate carotid artery stenosis confirmed by CTA, MRA, ultrasound, or DSA, with no anticipated need for surgical intervention.
- Modified Rankin Scale (mRS) score ≤ 2
- Signed informed consent form obtained from the subject
- Carotid ultrasound showing a plaque burden rate ≥30% at the most stenotic cross-sectional site of the carotid artery (common carotid artery or proximal C1 segment of the internal carotid artery).
Key exclusion criteria (14 listed)
- Non-atherosclerotic carotid stenosis, including arterial dissection, Takayasu arteritis, radiation-induced vasculopathy, fibromuscular dysplasia, neurofibromatosis, suspected vasospasm, or recanalized vascular embolism.
- Known cardioembolic sources: mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus/vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, chronic/paroxysmal atrial fibrillation. (Confound ASCVD outcome assessment.)
- History of cerebrovascular, coronary, or peripheral arterial endovascular intervention within 30 days before enrollment or anticipated surgery within the next 6 months.
- History of ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) before enrollment.
- Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
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 |
|---|---|---|
| PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± EzetimibePCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe | Drug | Exposure Group: PCSK9 Inhibitor + Statin ± Ezetimibe Group |
| Rosuvastatin/Atorvastatin ± EzetimibeRosuvastatin/atorvastatin ± ezetimibe | Drug | Non-exposed Group: Statin ± Ezetimibe Group |
Primary outcome
Change in plaque burden rate at the most stenotic carotid site at 180±7 days
Time frame: 180±7 days
10 secondary outcomes
Lipid profile (TG/TC/LDL-C/HDL-C), liver function (ALT, AST), CK at 30±3 days
Time frame: 30±3 days
Lipid profile: TG/TC/LDL-C/HDL-C; liver function: ALT, AST, CK at 180±7 days
Time frame: 180±7 days
Plaque burden rate at the most stenotic cross-sectional site of the carotid artery at 180±7 days
Time frame: 180±7 days
Plaque diameter stenosis at 180±7 days
Time frame: 180±7 days
Plaque dimensions (length × thickness) at 180±7 days
Time frame: 180±7 days
Plaque stability (hypoechoic regions, fibrous cap integrity, ulceration, plaque score) at 180±7 days
Time frame: 180±7 days
mRS score at 180±7 days
Time frame: 180±7 days
Time to first major vascular event within 180±7 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)
Time frame: within 180±7 days
mRS score at 365±30 days
Time frame: 365±30 days
Time to first major vascular event within 365±30 days (stroke/TIA, angina, myocardial infarction, symptomatic peripheral vascular disease)
Time frame: within 365±30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Researchers need to submit a formal data sharing application to the TRIP-CAS Steering Committee and obtain the approval of the Steering Committee.
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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.
Jianmin Liu principal investigator
Changhai Hospital
Pinjing Hui, MD, PhD principal investigator
The First Affiliated Hospital of Soochow University
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 Carotid Artery Stenosis, run by Changhai Hospital 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Li, MD, PhD (+86-13818803656, lqeimm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque burden rate at the most stenotic carotid site at 180±7 days (time frame: 180±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 7 Aug 2026.