Can a new drug help stroke patients recover better?
NCT ID NCT07739160
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial is testing whether an experimental drug called HRS-4029 can improve outcomes for people who have had an acute ischemic stroke, which happens when a blood clot blocks blood flow to the brain. The study will compare the drug against a placebo in about 340 participants who receive treatment within three hours of stroke onset. The main goal is to see if HRS-4029 helps reduce disability and improve recovery, as measured by standard stroke scales.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-4029
- What this could lead to
- If successful, HRS-4029 could become a new treatment to reduce disability and improve recovery after a stroke.
- What could go wrong
- This is an early-phase trial, so the drug may not prove effective or safe. Results from a larger population are needed before any conclusions can be drawn.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 85 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. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative); 2. Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset. 3. Clinical diagnosis of acute ischemic stroke (AIS). 4. Modified Rankin Scale (mRS) score ≤1 prior to stroke onset. 5. National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2. Exclusion Criteria: 1. Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; 2. Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2; 3. Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes. 4. Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment; 5. Severe hyperglycemia or hypoglycemia; 6. Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia; 7. History of severe hepatic impairment; 8. History of severe renal insufficiency; 9. Advanced malignancy or currently undergoing antineoplastic treatment; 10. Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening; 11. Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit; 12. Terminal illness with an estimated life expectancy of less than 1 year; 13. Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.
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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 Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better