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Not yet recruiting NCT07739160

The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

Phase II Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4029, Placebo.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy and Safety of HRS-4029 for the Treatment of Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial

Overview

This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).

Interventions

  • Drug HRS-4029
    HRS-4029
  • Drug Placebo
    Placebo

Primary outcome measures

  • The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2 [Time frame: Day 90]
Secondary outcome measures (5)
  • The Infarct Volume [Time frame: 24 hours]
  • The Proportion of Participants With Improvement of 4 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 [Time frame: Day 10]
  • The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1 [Time frame: Day 90]
  • Ordinal Modified Rankin Scale (mRS) Score [Time frame: Day 90]
  • The Proportion of Participants With a Barthel Index (BI) Score ≥ 95 [Time frame: Day 90]

Eligibility criteria

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).
  • Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
  • 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.
  • 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;
  • History of severe hepatic impairment;
  • History of severe renal insufficiency;
  • Advanced malignancy or currently undergoing antineoplastic treatment;
  • Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening;
  • 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;
  • Terminal illness with an estimated life expectancy of less than 1 year;
  • Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07739160 · HRS-4029-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗