NCT07233070进行中（未招募）2 期
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of HRS-7450 Injection in Patients With Acute Ischemic Stroke.
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- mRS score of 0-1 at 90 days
研究概览
简要总结
This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand and voluntarily participate in this study, and sign the informed consent form;
- •Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender;
- •Onset of symptoms within 4.5 to 24 hours;
- •Clinically diagnosed with acute ischemic stroke;
- •Pre-stroke modified Rankin Scale (mRS) score < 2;
- •National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 (inclusive) at screening;
- •Meet the imaging inclusion criteria;
- •Female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective contraception and avoid sperm/ova donation.
排除标准
- •Treatment with thrombolytic therapy.
- •Planned endovascular therapy.
- •Arterial dissection of the head, neck, or aorta.
- •Multiple infarctions across multiple large vascular territories.
- •NIHSS level of consciousness item 1a score >
- •Neurological deficits presenting after a seizure or post-ictal state, or the presence of other neurological conditions leading to uncooperative or unwillingness to cooperate with examination.
- •Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan.
- •Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
- •History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc.
- •History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months.
- •Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding.
- •Major surgery or severe trauma within the past 2 weeks.
- •Arterial puncture at a non-compressible site within the past week.
- •Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment.
- •Known significant bleeding tendency or severe coagulation disorder.
- •Blood glucose at screening >22.2 mmol/L or <2.8 mmol/L; subjects may be re-evaluated after active treatment.
- •Within the past 3 months: acute ST-segment elevation myocardial infarction (MI), and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or hospitalization for acute coronary syndrome, MI, cardiac arrest, or unplanned coronary intervention; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.
- •Significant liver disease history, or AST and/or ALT and/or GGT ≥3 × ULN, and/or total bilirubin (TBIL) ≥2 × ULN, or known congenital disorder of bilirubin metabolism.
- •Clinically significant severe renal disease, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- •History of hemolytic anemia due to various causes, currently under treatment or not meeting cure criteria.
- •Known allergy or hypersensitivity to HRS-7450 or any excipients in its formulation.
- •Treatment with therapeutic doses of heparin or low molecular weight heparin within 24 hours.
- •Use of oral anticoagulants within 48 hours, including vitamin K antagonists, direct thrombin inhibitors, factor Xa inhibitors, or other investigational anticoagulants.
- •Use of glycoprotein IIb/IIIa receptor inhibitors within 48 hours.
- •Female subjects who are pregnant or breastfeeding, or with a positive pregnancy test.
- •Participation in another drug or device clinical trial within the 3 months prior to screening.
- •Terminal illness with a life expectancy of less than 1 year.
- •Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
研究组 & 干预措施
Treatment group D: HRS-7450 Injection Placebo.
Placebo Comparator
干预措施: HRS-7450 Injection Placebo (Drug)
Treatment group A: HRS-7450 Injection
Experimental
干预措施: HRS-7450 Injection (Drug)
Treatment group B: HRS-7450 Injection
Experimental
干预措施: HRS-7450 Injection (Drug)
Treatment group C: HRS-7450 Injection
Experimental
干预措施: HRS-7450 Injection (Drug)
结局指标
主要结局
mRS score of 0-1 at 90 days
时间窗: within 90 days after the start of administration
次要结局
- Incidence of intracranial hemorrhage (ICH) within 7 days after dosing;(within 7 days after the start of administration)
- Incidence of major non-intracranial hemorrhage within 36 hours after dosing;(within 36 hours after the start of administration)
- Reperfusion rate at 24 hours;(within 24 hours after the start of administration)
- Recanalization rate at 24 hours;(within 24 hours after the start of administration)
- Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 24 hours;(within 24 hours after the start of administration)
- Infarct volume at 7 days;(within 7 days after the start of administration)
- Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 7 days;(within 7 days after the start of administration)
- NIHSS score at 14 days;(within 14 days after the start of administration)
- mRS score at 90 days;(within 90 days after the start of administration)
- Proportion of subjects with mRS score 0-2 at 90 days;(within 90 days after the start of administration)
- Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing;(within 36 hours after the start of administration)
- Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing;(within 7 days after the start of administration)
- Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing;(within 36 hours after the start of administration)
- Incidence of major non-intracranial hemorrhage within 7 days after dosing;(within 7 days after the start of administration)
- Mortality rate at 7 days after dosing;(within 7 days after the start of administration)
- Mortality rate at 90 days after dosing;(within 90 days after the start of administration)
研究者
研究点 (2)
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