The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients (NCT07739160) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
China340 participantsStarted 2026-08-15
Plain-language summary
This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
. Clinical diagnosis of acute ischemic stroke (AIS).
. 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
. Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.;
. Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2;
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for HRS-4029 and it hasn't started recruiting yet, what does that mean for how much is currently known about its safety and effectiveness in stroke patients like me?
2The trial measures success by whether patients reach an mRS score of 2 or less — which means being able to handle most daily activities independently — so based on my current condition, does my doctor think that level of recovery is a realistic goal, and does this trial align with where I'm starting from?
3Given that this trial is not yet recruiting, how urgent is my situation, and should we be pursuing standard treatments now rather than waiting to see if I might eventually be eligible for this study?
4What is HRS-4029, how does it work differently from existing treatments for acute ischemic stroke, and are there any early safety signals from prior research my doctor is aware of that I should factor into my thinking?
5If this trial does open and my doctor thinks it might be worth considering, what would the day-to-day demands of participating look like — such as hospital stays, travel, or follow-up visits — and how might that affect my recovery and family life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2
. Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment;
. Severe hyperglycemia or hypoglycemia;
. 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;