Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)NCT07341958
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
A study testing Tafolecimab in people with Ischemic Stroke or High-risk TIA (ABCD² ≥ 4), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) [Lp(a)] levels and the risk of stroke recurrence within 90… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
- What is being tested?
- Tafolecimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2026to 30 Aug 2027
- Phase
- Interventional
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 and 80 years, regardless of gender.
- For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol/L; for treatment-naïve patients: screening LDL-C ≥2.6 mmol/L.
- Lp(a) ≥30 mg/dL.
- Onset of symptoms within 3 to 7 days.
- Diagnosis of ischemic stroke (NIHSS score ≤20) or high-risk TIA with ABCD² score ≥4; and meeting at least one of the following imaging criteria:
- Large-artery atherosclerosis (LAA) subtype per TOAST classification: vascular imaging confirms ≥50% atherosclerotic stenosis of the intracranial or extracranial culprit artery.
- Head CT or MRI demonstrates acute multiple infarcts, with etiology consistent with large-artery atherosclerosis (including nonstenotic vulnerable plaques).
- 6.The patient or their legally authorized representative has provided written informed consent.
Who cannot join
- Have received or are planned to receive intravenous thrombolysis or endovascular thrombectomy;
- Definite cardioembolic ischemic cerebrovascular disease, such as that associated with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis, etc.;
- Ischemic cerebrovascular disease with other definite etiologies, such as aortic dissection, cervical or intracranial arterial dissection, vasculitis, vascular malformation, moyamoya disease/moyamoya syndrome, fibromuscular dysplasia, etc.;
- Non-vascular intracranial diseases, such as intracranial tumors, multiple sclerosis, etc.;
- Neuroimaging showing that the infarct area of the index cerebral infarction involves more than one-half of a single cerebral lobe;
- Neuroimaging showing hemorrhagic transformation of the index cerebral infarction;
Show all 21Show fewer
- Pre-stroke modified Rankin Scale (mRS) score >1;
- Known hypersensitivity to tafolecimab or any other contraindication to its use;
- Use of immunosuppressive agents, antifungal agents, fibrates, or other medications that may affect statin metabolism within 14 days prior to randomization;
- Creatine kinase (CK) level >5 times the upper limit of normal (ULN) after symptom onset;
- Severe hepatic or renal impairment prior to randomization. Severe hepatic impairment is defined as alanine aminotransferase (ALT) >2 times the ULN or aspartate aminotransferase (AST) >2 times the ULN; severe renal impairment is defined as serum creatinine >1.5 times the ULN or glomerular filtration rate (GFR) <40 mL/min/1.73 m²;
- History of intracranial hemorrhage, such as intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH);
- History of intracranial or extracranial angioplasty;
- History of gastrointestinal bleeding or major surgery within the previous 90 days;
- Planned surgery or interventional procedure within 90 days that may require discontinuation of the study treatment;
- Severe organic disease with an expected survival of less than 1 year;
- Pregnant women, or women of childbearing potential who are not using effective contraception and have no documented pregnancy test;
- Currently participating in another clinical trial involving an investigational drug or device;
- Unable to complete follow-up due to geographic or other reasons, such as alcohol abuse, drug abuse, dementia, or severe psychiatric disorders;
- Use of a PCSK9 inhibitor, including monoclonal antibodies or small interfering RNA (siRNA), within the previous 6 months;
- Thrombocytopenia (platelet count <100 × 10⁹/L), coagulation disorders, or systemic bleeding.
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
Beijing Tiantan Hopital, Capital Medical University
Beijing
Dingwen Zhang, 0086-010-59975807, dingwen989100@163.com
About this study
Official title: INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)：A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) [Lp(a)] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg/dL).
Read the detailed description
Atherosclerotic stroke, particularly the large-artery atherosclerosis (LAA) subtype, carries a high risk of recurrence despite standard lipid-lowering therapy with statins. Elevated Lipoprotein(a) [Lp(a)] is a key genetic, pro-atherogenic risk factor largely unaffected by conventional statins and is independently associated with an increased risk of LAA-type stroke recurrence, representing a significant unmet residual risk. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide a dual-pathway approach by potently lowering both low-density lipoprotein cholesterol (LDL-C) and Lp(a) levels.Evidence on the benefits of early, intensive lipid-lowering with PCSK9 inhibitors specifically for secondary stroke prevention in high-risk LAA patients with elevated Lp(a) is lacking. The primary purpose of this study is to evaluate the efficacy and safety of adding tafolecimab, a novel PCSK9 inhibitor, to standard lipid-lowering therapy in reducing Lp(a) levels at 90 days in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA) of LAA etiology and elevated Lp(a). Secondary objectives include assessing its impact on LDL-C control, preliminary clinical outcomes (stroke recurrence, composite vascular events), safety, and exploring biomarker associations. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 242 patients from multiple centers in China will be enrolled. Key eligibility criteria include: age 35-80 years, acute ischemic stroke or high-risk TIA (ABCD² ≥4) of large-artery atherosclerosis (LAA) etiology occurring 3-7 days before randomization, and lipoprotein(a) [Lp(a)] ≥30 mg/dL. Patients will be stratified by site and randomly assigned in a 1:1 ratio to receive either standard lipid-lowering therapy (statin ± ezetimibe) plus tafolecimab (a PCSK9 monoclonal antibody) or standard therapy plus matching placebo for 90 days. Study treatment will be initiated as soon as possible after randomization. Face-to-face visits are scheduled at baseline, day 7 (or hospital discharge), and months 1, 2, and 3 after randomization. At each visit, neurological status (NIHSS, mRS), vital signs, concomitant medications, and adverse events will be recorded. Fasting blood samples will be collected at baseline, month 1, month 2, and month 3 for central laboratory measurement of Lp(a), LDL-C, apolipoprotein B, high-sensitivity C-reactive protein, and interleukin-6. Additional safety laboratories (liver function, renal function, creatine kinase, complete blood count) will be performed at baseline, day 7, and month 3. The primary efficacy endpoint is the percent change in Lp(a) from baseline to 90 days, analyzed using a repeated-measures mixed-effects model (MMRM) with adjustment for baseline value. The key secondary efficacy endpoints include: percent change in LDL-C at 90 days, proportion of patients achieving LDL-C goal (<1.8 mmol/L or ≥50% reduction), and the occurrence of stroke recurrence, composite vascular events (ischemic stroke, myocardial infarction, hospitalization for unstable angina or heart failure, cardiovascular death), and all-cause death within 90 days. Safety endpoints comprise the incidence of adverse events, serious adverse events, bleeding events (GUSTO classification), hepatotoxicity (ALT/AST >3× ULN), myotoxicity (CK >10× ULN or clinical muscle symptoms), and injection-site reactions. The sample size was calculated to provide 80% power to detect a 25% between-group difference in Lp(a) reduction at 90 days, assuming a standard deviation of 67.34% and a two-sided alpha of 0.05, with an anticipated 5% dropout rate. Efficacy analyses will be performed on the intention-to-treat (ITT) population, while safety analyses will include all patients who received at least one dose of study drug. Time-to-event endpoints will be analyzed using Kaplan-Meier estimates and Cox proportional-hazards models. Continuous secondary endpoints will be assessed using MMRM or analysis of covariance.
- Being tested
- Tafolecimab, Placebo
- Keywords
- PCSK9 inhibitor, lipid-lowering therapy, ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafolecimabDrug
Treatment should be initiated as soon as possible after randomization, with Tafolecimab administered subcutaneously once every two weeks for a total duration of 90 days.
All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.
PlaceboDrug
Treatment should be initiated as soon as possible after randomization, with Tafolecimab placebo administered subcutaneously once every two weeks for a total duration of 90 days.
All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses.
| Study group | Role | What they receive |
|---|---|---|
| Standard lipid-lowering therapy(statin therapy with or without ezetimibe) + Tafolecimab | Experimental | Not described Receives: Drug: Tafolecimab |
| Standard lipid-lowering therapy (statin therapy with or without ezetimibe)+Tafolecimab placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Lp(a) from baseline at 90 days.
Measured: From baseline to 90 days after randomization
Secondary outcomes (17)
Incidence of new stroke (including hemorrhagic and ischemic stroke) within 90 days.
Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke
Measured: From baseline to 90 days after randomization
Incidence of composite clinical endpoint events within 90 days
Including recurrent ischemic stroke, myocardial infarction, rehospitalization for unstable angina or heart failure, and cardiovascular death
Measured: From baseline to 90 days after randomization
Incidence of myocardial infarction within 90 days.
Acute myocardial infarction is diagnosed by the third edition of the international general diagnostic criteria (Glob Heart. 2012 Dec;7(4):275-95)
Measured: From baseline to 90 days after randomization
Incidence of vascular death within 90 days.
Vascular death includes stroke, sudden cardiac death, acute myocardial infarction, heart failure, pulmonary embolism, heart / cerebrovascular intervention or surgery (death unrelated to acute MI) and other cardiovascular causes of death [such as: Arrhythmia irrelevant with sudden cardiac death, aortic aneurysm rupture, or peripheral artery disease. Any death of unknown/unclear cause that occurs within 30 days after stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery will be regarded as death due to stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery, respectively.
Measured: From baseline to 90 days after randomization
Incidence of all-cause death within 90 days.
Measured: From baseline to 90 days after randomization
Proportion of patients with poor functional outcome (mRS score 2-6) at 90 days.
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. The modified Rankin Scale (mRS)= 2-6: poor functional outcome
Measured: From baseline to 90 days after randomization
Proportion of patients with Lp(a) <30 mg/dL at 90 days
Measured: From baseline to 90 days after randomization
Percent reduction in ApoB and LDL-C levels from baseline to 90 days
Measured: From baseline to 90 days after randomization
LDL-C goal attainment rate (<1.8 mmol/L or reduction ≥ 50%) at 90 days
Measured: From baseline to 90 days after randomization
Moderate and severe bleeding events (GUSTO classification)
The GUSTO classification provides a three-tiered (severe, moderate, mild), criteria-driven framework for consistently reporting bleeding complications in clinical research, with a focus on hemodynamic impact and objective laboratory/transfusion data.
Measured: From baseline to 90 days after randomization
Hepatotoxicity: Post-treatment ALT or AST levels exceeding 3 times the upper limit of normal upon re-measurement
Hepatotoxicity in this context is defined as a confirmed elevation of liver enzymes after treatment. Specifically, it means that a follow-up blood test shows either ALT or AST levels to be more than three times higher than the normal limit. This is a standard safety criterion for detecting potential drug-induced liver injury in clinical trials.
Measured: From baseline to 90 days after randomization
Muscle toxicity
Post-treatment creatine kinase levels exceeding 10 times the upper limit of normal upon re-measurement, or occurrence of skeletal muscle adverse events (myalgia, myopathy, or rhabdomyolysis)
Measured: From baseline to 90 days after randomization
Upper Respiratory Tract Infection (URTI):
Common infections affecting the nose, sinuses, throat, or larynx (e.g., common cold, sinusitis). These are general illnesses, not necessarily treatment-related.
Measured: From baseline to 90 days after randomization
Urinary Tract Infection (UTI)
An infection in any part of the urinary system (bladder, urethra, kidneys). It is monitored as a common potential infection during trials.
Measured: From baseline to 90 days after randomization
Injection Site Reactions:
Including papules, bleeding, discoloration, pain, itching, rash, induration, erythema, swelling, etc., at the injection site
Measured: From baseline to 90 days after randomization
Allergic Reactions:
Undesirable immune system responses to the treatment, ranging from mild (rash, itching) to severe, life-threatening anaphylaxis.
Measured: From baseline to 90 days after randomization
Other Adverse Events/Serious Adverse Events (AEs/SAEs):
Other Adverse Events/Serious Adverse Events (AEs/SAEs):
Measured: From baseline to 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start8 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341958
- Sponsor's protocol ID
- HX-A-2025103
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)：A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07341958
- Acronym / sponsor ID
- HX-A-2025103
- Keywords
- PCSK9 inhibitor, lipid-lowering therapy, ischemic stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) [Lp(a)] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg/dL).
Detailed description
Atherosclerotic stroke, particularly the large-artery atherosclerosis (LAA) subtype, carries a high risk of recurrence despite standard lipid-lowering therapy with statins. Elevated Lipoprotein(a) [Lp(a)] is a key genetic, pro-atherogenic risk factor largely unaffected by conventional statins and is independently associated with an increased risk of LAA-type stroke recurrence, representing a significant unmet residual risk. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide a dual-pathway approach by potently lowering both low-density lipoprotein cholesterol (LDL-C) and Lp(a) levels.Evidence on the benefits of early, intensive lipid-lowering with PCSK9 inhibitors specifically for secondary stroke prevention in high-risk LAA patients with elevated Lp(a) is lacking. The primary purpose of this study is to evaluate the efficacy and safety of adding tafolecimab, a novel PCSK9 inhibitor, to standard lipid-lowering therapy in reducing Lp(a) levels at 90 days in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA) of LAA etiology and elevated Lp(a). Secondary objectives include assessing its impact on LDL-C control, preliminary clinical outcomes (stroke recurrence, composite vascular events), safety, and exploring biomarker associations. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 242 patients from multiple centers in China will be enrolled. Key eligibility criteria include: age 35-80 years, acute ischemic stroke or high-risk TIA (ABCD² ≥4) of large-artery atherosclerosis (LAA) etiology occurring 3-7 days before randomization, and lipoprotein(a) [Lp(a)] ≥30 mg/dL. Patients will be stratified by site and randomly assigned in a 1:1 ratio to receive either standard lipid-lowering therapy (statin ± ezetimibe) plus tafolecimab (a PCSK9 monoclonal antibody) or standard therapy plus matching placebo for 90 days. Study treatment will be initiated as soon as possible after randomization. Face-to-face visits are scheduled at baseline, day 7 (or hospital discharge), and months 1, 2, and 3 after randomization. At each visit, neurological status (NIHSS, mRS), vital signs, concomitant medications, and adverse events will be recorded. Fasting blood samples will be collected at baseline, month 1, month 2, and month 3 for central laboratory measurement of Lp(a), LDL-C, apolipoprotein B, high-sensitivity C-reactive protein, and interleukin-6. Additional safety laboratories (liver function, renal function, creatine kinase, complete blood count) will be performed at baseline, day 7, and month 3. The primary efficacy endpoint is the percent change in Lp(a) from baseline to 90 days, analyzed using a repeated-measures mixed-effects model (MMRM) with adjustment for baseline value. The key secondary efficacy endpoints include: percent change in LDL-C at 90 days, proportion of patients achieving LDL-C goal (<1.8 mmol/L or ≥50% reduction), and the occurrence of stroke recurrence, composite vascular events (ischemic stroke, myocardial infarction, hospitalization for unstable angina or heart failure, cardiovascular death), and all-cause death within 90 days. Safety endpoints comprise the incidence of adverse events, serious adverse events, bleeding events (GUSTO classification), hepatotoxicity (ALT/AST >3× ULN), myotoxicity (CK >10× ULN or clinical muscle symptoms), and injection-site reactions. The sample size was calculated to provide 80% power to detect a 25% between-group difference in Lp(a) reduction at 90 days, assuming a standard deviation of 67.34% and a two-sided alpha of 0.05, with an anticipated 5% dropout rate. Efficacy analyses will be performed on the intention-to-treat (ITT) population, while safety analyses will include all patients who received at least one dose of study drug. Time-to-event endpoints will be analyzed using Kaplan-Meier estimates and Cox proportional-hazards models. Continuous secondary endpoints will be assessed using MMRM or analysis of covariance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A multicenter, randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard lipid-lowering therapy(statin therapy with or without ezetimibe) + Tafolecimab | Experimental | Drug: Tafolecimab |
| Standard lipid-lowering therapy (statin therapy with or without ezetimibe)+Tafolecimab placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 35 and 80 years, regardless of gender.
- For patients with prior lipid-lowering treatment: screening LDL-C ≥1.8 mmol/L; for treatment-naïve patients: screening LDL-C ≥2.6 mmol/L.
- Lp(a) ≥30 mg/dL.
- Onset of symptoms within 3 to 7 days.
- Diagnosis of ischemic stroke (NIHSS score ≤20) or high-risk TIA with ABCD² score ≥4; and meeting at least one of the following imaging criteria:
Key exclusion criteria (21 listed)
- Have received or are planned to receive intravenous thrombolysis or endovascular thrombectomy;
- Definite cardioembolic ischemic cerebrovascular disease, such as that associated with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis, etc.;
- Ischemic cerebrovascular disease with other definite etiologies, such as aortic dissection, cervical or intracranial arterial dissection, vasculitis, vascular malformation, moyamoya disease/moyamoya syndrome, fibromuscular dysplasia, etc.;
- Non-vascular intracranial diseases, such as intracranial tumors, multiple sclerosis, etc.;
- Neuroimaging showing that the infarct area of the index cerebral infarction involves more than one-half of a single cerebral lobe;
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 |
|---|---|---|
| TafolecimabTreatment should be initiated as soon as possible after randomization, with Tafolecimab administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses. | Drug | Standard lipid-lowering therapy(statin therapy with or without ezetimibe) + Tafolecimab |
| PlaceboTreatment should be initiated as soon as possible after randomization, with Tafolecimab placebo administered subcutaneously once every two weeks for a total duration of 90 days. All patients received standard lipid-lowering therapy as recommended by stroke secondary prevention guidelines, including intensive statin treatment with or without ezetimibe, administered at maximally tolerated doses. | Drug | Standard lipid-lowering therapy (statin therapy with or without ezetimibe)+Tafolecimab placebo |
Primary outcome
Percentage change in Lp(a) from baseline at 90 days.
Time frame: From baseline to 90 days after randomization
17 secondary outcomes
Incidence of new stroke (including hemorrhagic and ischemic stroke) within 90 days.
Time frame: From baseline to 90 days after randomization
Incidence of composite clinical endpoint events within 90 days
Time frame: From baseline to 90 days after randomization
Incidence of myocardial infarction within 90 days.
Time frame: From baseline to 90 days after randomization
Incidence of vascular death within 90 days.
Time frame: From baseline to 90 days after randomization
Incidence of all-cause death within 90 days.
Time frame: From baseline to 90 days after randomization
Proportion of patients with poor functional outcome (mRS score 2-6) at 90 days.
Time frame: From baseline to 90 days after randomization
Proportion of patients with Lp(a) <30 mg/dL at 90 days
Time frame: From baseline to 90 days after randomization
Percent reduction in ApoB and LDL-C levels from baseline to 90 days
Time frame: From baseline to 90 days after randomization
LDL-C goal attainment rate (<1.8 mmol/L or reduction ≥ 50%) at 90 days
Time frame: From baseline to 90 days after randomization
Moderate and severe bleeding events (GUSTO classification)
Time frame: From baseline to 90 days after randomization
Hepatotoxicity: Post-treatment ALT or AST levels exceeding 3 times the upper limit of normal upon re-measurement
Time frame: From baseline to 90 days after randomization
Muscle toxicity
Time frame: From baseline to 90 days after randomization
Upper Respiratory Tract Infection (URTI):
Time frame: From baseline to 90 days after randomization
Urinary Tract Infection (UTI)
Time frame: From baseline to 90 days after randomization
Injection Site Reactions:
Time frame: From baseline to 90 days after randomization
Allergic Reactions:
Time frame: From baseline to 90 days after randomization
Other Adverse Events/Serious Adverse Events (AEs/SAEs):
Time frame: From baseline to 90 days after randomization
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tafolecimab in people with Ischemic Stroke or High-risk TIA (ABCD² ≥ 4), run by Beijing Tiantan 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 8 inclusion and 21 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 8 Oct 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. 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.
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 Yuesong Pan (0086-010-59975807, yuesongpan@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Lp(a) from baseline at 90 days. (time frame: From baseline to 90 days after randomization). 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 8 Oct 2026.