New shot could cut stroke risk for High-Risk patients
NCT ID NCT07341958
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a drug called Tafolecimab to standard cholesterol-lowering therapy can reduce the risk of another stroke in people who have had a recent stroke or mini-stroke and have high levels of Lp(a), a type of fat in the blood. About 242 participants will receive either the drug or a placebo shot every two weeks for 90 days. The main goal is to see if Lp(a) levels drop and if fewer strokes occur.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tafolecimab (a PCSK9 inhibitor drug given as a shot every two weeks)
- What this could lead to
- If it works, this could point toward a new way to reduce stroke risk in people with high Lp(a) levels who are already on standard cholesterol-lowering therapy.
- What could go wrong
- This is a small, early-stage trial (242 participants) testing a short-term treatment (90 days). The results may not apply to everyone, and the drug could have side effects or fail to reduce stroke recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 242 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 35 and 80 years, regardless of gender. 2. 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. 3. Lp(a) ≥50 mg/dL. 4. Onset of symptoms within 3 to 7 days. 5. 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: (1) Large-artery atherosclerosis (LAA) subtype per TOAST classification: vascular imaging confirms ≥50% atherosclerotic stenosis of the intracranial or extracranial culprit artery. (2) 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. Exclusion Criteria: 1. Patients who have undergone or are scheduled to undergo thrombolysis or thrombectomy therapy. 2. Definite cardiogenic ischemic cerebrovascular disease (e.g., accompanied by atrial fibrillation, prosthetic heart valves, atrial myxoma, infective endocarditis, etc.). 3. Other clearly identified etiologies of ischemic cerebrovascular disease (e.g., aortic dissection, cervical/cerebral arterial dissection, vasculitis, vascular malformations, moyamoya disease/syndrome, fibromuscular dysplasia, etc.). 4. Non-vascular intracranial diseases (e.g., intracranial tumors, multiple sclerosis, etc.). 5. Imaging findings indicating that the current cerebral infarction area exceeds 1/2 of a single brain lobe. 6. Imaging findings indicating hemorrhagic transformation of the current cerebral infarction. 7. Pre-stroke mRS score \> 2. 8. Patients with known allergies to Tafolecimab or other contraindications for its use. 9. Use of immunosuppressive drugs, antifungal drugs, or fibrates (which affect statin metabolism) within 14 days prior to randomization. 10. Creatine kinase levels exceeding 5 times the upper limit of normal after the onset of the event. 11. Severe hepatic or renal insufficiency prior to randomization (Note: Severe hepatic insufficiency is defined as ALT \>2×ULN or AST \>2×ULN; severe renal insufficiency is defined as serum creatinine \>1.5×ULN or GFR \<40 ml/min/1.73m²). 12. History of intracranial hemorrhage (e.g., ICH, SAH). 13. History of intracranial or extracranial vascular angioplasty. 14. History of gastrointestinal bleeding or major surgery within 90 days prior to enrollment. 15. Planned surgical or interventional procedures within the next 90 days that may necessitate discontinuation of the investigational drug. 16. Suffering from severe organic diseases with an expected survival time of less than 1 year. 17. Pregnant women, or women of childbearing potential who are not using effective contraception and lack documented pregnancy test results. 18. Currently participating in other investigational drug or device trials. 19. Inability to cooperate with follow-up due to geographic, social, or other reasons (e.g., alcohol abuse, substance abuse, dementia, severe psychiatric disorders, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hopital, Capital Medical University
Beijing, China
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