An observational study in Carotid Artery Stenosis, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Changhai Hospital · Observational
Among 70 studies in Carotid Stenosis with a site in China — 32 open to participants now, 36 under way, 1 of them phase 3. Carotid Stenosis · China.
Among the 70 studies in Carotid Stenosis with a site in China, this one is the 12th largest by planned enrollment of the 34 observational ones that give a count, is one of 8 that started in 2025, is one of 34 observational ones, reaches primary completion later than 22 of the 35 other live ones, and was the 61st registered.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
Browse Carotid Stenosis studies →32 of the 70 studies in Carotid Stenosis with a site in China are open now. Recruiting first, the newest first:
The Fifth Affiliated Hospital of Wenzhou Medical University & Lishui Central Hospital · Sites in China
Ages 30–80
Beijing Tiantan Hospital · Sites in China
Ages 18+
General Hospital of Shenyang Military Region · Sites in China
Ages 40+
Chinese PLA General Hospital · Sites in China
Ages 10–90
Beijing Anzhen Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 60 Carotid Stenosis studies recruiting now, 38 (63%) set no upper age limit and none (0%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
70 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 406 is above the median of 176 across 159 observational studies indexed under Carotid Stenosis.
Median enrollment 177 across the 36 interventional studies, 200 across the 34 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 70 have an industry lead sponsor. The 10 most frequent:
Changhai Hospital is the lead sponsor of 355 studies on the registry; 136 are open to participants now.
Changhai Hospital has 1 study filed under Carotid Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Carotid Stenosis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07004673Ruijin Hospital18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients | 2026-12-31 |
| NCT05134246Xuanwu Hospital, BeijingCarotid Revascularization for Radiation Induced Carotid Artery Stenosis | 2026-12-31 |
| NCT07036991Changhai HospitalA Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis | 2027-06-01 |
| NCT07247864Beijing Anzhen HospitalBalloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting | 2027-09-01 |
| NCT07412249General Hospital of Shenyang Military RegionRemote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 70 studies in Carotid Stenosis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A multicenter cohort study
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical inclusion criteria:
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).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day
Drug: PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe
Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day
Drug: Rosuvastatin/Atorvastatin ± Ezetimibe
PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe
Rosuvastatin/atorvastatin ± ezetimibe
Change in plaque burden rate at the most stenotic carotid site at 180±7 days
Time frame: 180±7 days
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
Deaths within 180±7 days after enrolment
Time frame: within 180±7 days after enrolment
SAEs within 180±7 days after enrolment
Time frame: within 180±7 days after enrolment
ALT/AST >2× upper limit, CK >3× upper limit within 180±7 days after enrolment
Time frame: within 180±7 days after enrolment
Deaths within 365±30 days after enrolment
Time frame: within 365±30 days after enrolment
SAEs within 365±30 days after enrolment
Time frame: within 365±30 days after enrolment
ALT/AST >2× upper limit, CK >3× upper limit within 365±30 days after enrolment
Time frame: within 365±30 days after enrolment
Plan to share: Yes — Researchers need to submit a formal data sharing application to the TRIP-CAS Steering Committee and obtain the approval of the Steering Committee.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data sharing will be available from 12 months after the publication of the main results.
Access criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4.Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5.The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
Data sharing details ↗ · www.ocin.org.cn
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Of 79 non-industry observational studies under Carotid Stenosis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 104. This study's planned 20 months is below that.
Counting every sponsor, half of 87 studies reached it within 50 months; a quarter within 30 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.