Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New shot could cut stroke risk for High-Risk patients

NCT ID NCT07341958

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 242 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

35 to 80 years

Sex

Anyone

Healthy volunteers

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

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.).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for High-risk transient ischemic attack are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tiantan Hopital, Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.