Symptomatic Intracranial Atherosclerotic StenosisPhase 3PICASSONCT07119918
PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis
A Phase 3 study testing Recaticimab in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Symptomatic Intracranial Atherosclerotic Stenosis
- What is being tested?
- Recaticimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,276 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2029
- Phase
- Phase 3
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged ≥30 years and ≤80 years.
- Patients aged between 30 to 49 are required to meet at least one of the following criteria:
- Insulin dependent diabetes for at least 15 years.
- At least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dL or HDL < 40 mg/dL or fasting triglycerides > 150 mg/dL or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.
- History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.
- Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic.
Show all 11Show fewer
- Aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.
- 2. Diagnosed with acute ischemic stroke or moderate-to-high risk transient ischemic attack (ABCD2 score ≥4).
- 3. CTA or DSA confirmed intracranial atherosclerotic stenosis >50%, which was responsible for the incident.
- 4. The time from symptom onset to initiation of study treatment is within 7 days.
- 5. Signed informed consent.
Who cannot join
- Baseline NIHSS ≥26.
- Suspected cardiogenic ischemic cerebrovascular diseases (e.g., combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.).
- Source of symptoms is possible related to ipsilateral carotid disease.
- Other ischemic cerebrovascular diseases with specific causes (e.g., aortic dissection, vasculitis, vascular malformation, etc.).
- Non-cerebral vascular disease (e.g., intracranial tumors, multiple sclerosis).
- Hemorrhagic stroke or hemorrhagic transformation of cerebral infarction before randomization.
Show all 15Show fewer
- Pre-existing contraindications of using PCSK9 inhibitors.
- Use of any PCSK9 inhibitors within the past 3 months.
- Pregnant or childbearing-age women who have no effective contraceptives or positive pregnancy test records.
- Patients who are participating in other trials.
- Hepatic or renal dysfunction, defined as AST and/or ALT >3ULN，eGFR<30mL/min, or Crea >220μmol/L (2.5mg/dL).
- Uncontrolled hypertension defined as systolic blood pressure (BP) >220mmHg or diastolic BP >120mmHg.
- Life expectancy is less than 1 year due to severe non-cardiovascular disease.
- Angioplasty or stenting procedure is planned before randomization.
- Unable to finish the follow-up visit due to geographical factor or other reasons (e.g., dementia, alcoholism, substance abuse, severe mental disease, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xinguang Yang contact
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yaxuan Pi, 86-20-81332619, piyx@mail2.sysu.edu.cn
Xinguang Yang, yangxinguang0926@163.com
About this study
Official title: PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (PICASSO): A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.
Read the detailed description
This is an investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial to determine the efficacy of Recaticimab (PCSK9 inhibitor) administered within 7 days of symptom onset in patients with symptomatic intracranial atherosclerotic stenosis (sICAS) in reducing incident stroke within 1 year.
Study intervention: (1) Participants in the intervention group will receive Recaticimab 300mg subcutaneous Q8W for 1 year. (2) Participants in the control group will receive matched placebo subcutaneous Q8W for 1 year. All participants will receive best medical management (BMM), including intensive statins treatment and dual antiplatelet therapy.
A total of 5276 participants are anticipated to be recruited for this study. Eligible participants will be 1:1 randomly assigned to receive Recaticimab or placebo.
- Being tested
- Recaticimab, Placebo
- Keywords
- symptomatic intracranial atherosclerotic stenosis, Recaticimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecaticimabDrug
Recaticimab 300mg subcutaneous Q8W for 1 year.
PlaceboDrug
Matched placebo subcutaneous Q8W for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Recaticimab group | Experimental | Not described Receives: Drug: Recaticimab |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any new stroke
Any new ischemic or hemorrhagic stroke within 1 year
Measured: 1 year (±2) weeks
Secondary outcomes (13)
Composite cardiovascular events
Composite cardiovascular events (non-fatal stroke, myocardial infarction, and death from cardiovascular causes) within 1 year.
Measured: 1 year (±2) weeks
Ischemic stroke
Any new ischemic stroke within 1 year.
Measured: 1 year (±2) weeks
Hemorrhagic stroke
Any new hemorrhagic stroke within 1 year.
Measured: 1 year (±2) weeks
Non-fatal stroke
Any non-fatal stroke within 1 year.
Measured: 1 year (±2) weeks
Myocardial infarction
Any myocardial infarction within 1 year.
Measured: 1 year (±2) weeks
Death from cardiovascular causes
Any death from cardiovascular causes within 1 year.
Measured: 1 year (±2) weeks
Quality of life (EQ-5D-5L)
1-year quality of life measured by EQ-5D-5L.
Measured: 1 year (±2) weeks
NIHSS scores
NIHSS scores at 7 days or discharge.
Measured: 7(±1) days or discharge
Modified Rankin Scale score at 90 days
The shift analysis of the 90-day mRS at 90 days.
Measured: 90 (±14) days
Modified Rankin Scale score at 1 year
The shift analysis of the 90-day mRS at 1 year.
Measured: 1 year (±2) weeks
Safety outcome: intracranial hemorrhage
Symptomatic intracranial hemorrhage within 1 year.
Measured: 1 year (±2) weeks
Safety outcome: Death
Death within 1 year.
Measured: 1 year (±2) weeks
Safety outcome: Serious Adverse Event (SAE)
Any SAE within 1 year.
Measured: 1 year (±2) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Intracranial Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,276 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119918
- Sponsor's protocol ID
- PICASSO
- Acronym
- PICASSO
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from Principal Investigators (Prof. Yamei Tang) upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (PICASSO): A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07119918
- Acronym / sponsor ID
- PICASSO / PICASSO
- Keywords
- symptomatic intracranial atherosclerotic stenosis, Recaticimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,276 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 13 Aug 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.
An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.
Detailed description
This is an investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial to determine the efficacy of Recaticimab (PCSK9 inhibitor) administered within 7 days of symptom onset in patients with symptomatic intracranial atherosclerotic stenosis (sICAS) in reducing incident stroke within 1 year.
Study intervention: (1) Participants in the intervention group will receive Recaticimab 300mg subcutaneous Q8W for 1 year. (2) Participants in the control group will receive matched placebo subcutaneous Q8W for 1 year. All participants will receive best medical management (BMM), including intensive statins treatment and dual antiplatelet therapy.
A total of 5276 participants are anticipated to be recruited for this study. Eligible participants will be 1:1 randomly assigned to receive Recaticimab or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recaticimab group | Experimental | Drug: Recaticimab |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Aged ≥30 years and ≤80 years.
- Patients aged between 30 to 49 are required to meet at least one of the following criteria:
- Insulin dependent diabetes for at least 15 years.
- At least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dL or HDL < 40 mg/dL or fasting triglycerides > 150 mg/dL or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.
- History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.
Key exclusion criteria (15 listed)
- Baseline NIHSS ≥26.
- Suspected cardiogenic ischemic cerebrovascular diseases (e.g., combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.).
- Source of symptoms is possible related to ipsilateral carotid disease.
- Other ischemic cerebrovascular diseases with specific causes (e.g., aortic dissection, vasculitis, vascular malformation, etc.).
- Non-cerebral vascular disease (e.g., intracranial tumors, multiple sclerosis).
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 |
|---|---|---|
| RecaticimabRecaticimab 300mg subcutaneous Q8W for 1 year. | Drug | Recaticimab group |
| PlaceboMatched placebo subcutaneous Q8W for 1 year. | Drug | Placebo group |
Primary outcome
Any new stroke
Time frame: 1 year (±2) weeks
Any new ischemic or hemorrhagic stroke within 1 year
13 secondary outcomes
Composite cardiovascular events
Time frame: 1 year (±2) weeks
Ischemic stroke
Time frame: 1 year (±2) weeks
Hemorrhagic stroke
Time frame: 1 year (±2) weeks
Non-fatal stroke
Time frame: 1 year (±2) weeks
Myocardial infarction
Time frame: 1 year (±2) weeks
Death from cardiovascular causes
Time frame: 1 year (±2) weeks
Quality of life (EQ-5D-5L)
Time frame: 1 year (±2) weeks
NIHSS scores
Time frame: 7(±1) days or discharge
Modified Rankin Scale score at 90 days
Time frame: 90 (±14) days
Modified Rankin Scale score at 1 year
Time frame: 1 year (±2) weeks
Safety outcome: intracranial hemorrhage
Time frame: 1 year (±2) weeks
Safety outcome: Death
Time frame: 1 year (±2) weeks
Safety outcome: Serious Adverse Event (SAE)
Time frame: 1 year (±2) weeks
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 13 Aug 2025.
- Individual participant dataSharing planned: Yes. The IPD will be available from Principal Investigators (Prof. Yamei Tang) upon reasonable request 6 months after the trial completion.
Related trials for Symptomatic Intracranial Atherosclerotic Stenosis
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
Not yet recruiting
Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
Symptomatic Intracranial Atherosclerotic Stenosis
Recruiting
Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis
Symptomatic Intracranial Atherosclerotic Stenosis
Active, not recruiting
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
Stroke, Intracranial Atherosclerotic Stenosis
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.
Xinguang Yang contact
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recaticimab in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 11 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 Aug 2025. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yaxuan Pi (86-20-81332619, piyx@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any new stroke (time frame: 1 year (±2) weeks). 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 13 Aug 2025.