A Prospective Multicenter Cohort Registry Study of Intravenous Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset (PRISM)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Excellent Functional Outcome at 90 Days
研究概览
简要总结
Acute ischemic stroke is a major cause of disability and death. Intravenous thrombolytic therapy is an important treatment option when given within the appropriate time window. Recombinant human prourokinase (rhPro-UK) is a thrombolytic medication approved for the treatment of acute ischemic stroke within 4.5 hours after symptom onset in China.
This prospective, multicenter cohort registry study aims to evaluate the effectiveness and safety of intravenous rhPro-UK in patients with acute ischemic stroke treated within 4.5 hours of symptom onset. Approximately 3,000 patients from multiple centers will be enrolled and followed for 90 days. Clinical outcomes, bleeding events, adverse events, and functional recovery will be collected and analyzed to provide further evidence on the use of rhPro-UK in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years, regardless of sex.
- •Pre-stroke modified Rankin Scale (mRS) score of 0-
- •Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
- •Written informed consent obtained from the participant or legally authorized representative.
排除标准
- •Known severe hypersensitivity to recombinant human prourokinase.
- •Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up.
- •Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy).
- •Blood glucose <2.8 mmol/L or >22.2 mmol/L that remains uncontrolled after correction.
- •Active internal bleeding or high bleeding risk, including gastrointestinal or urinary tract bleeding within 21 days, major surgery, severe trauma, major organ biopsy within 21 days, non-compressible arterial puncture within 7 days, or other significant bleeding risks.
- •Known coagulation abnormalities or bleeding tendency, including platelet count <100 × 10⁹/L, INR >1.7, clinically significant PT prolongation, clinically significant APTT prolongation, or markedly decreased fibrinogen levels.
- •Current or recent anticoagulant use associated with increased bleeding risk, including vitamin K antagonists with INR >1.7, direct thrombin inhibitors or factor Xa inhibitors within 48 hours with abnormal coagulation tests, or heparin within 24 hours with elevated APTT.
- •History of ischemic stroke, severe head trauma, or myocardial infarction within 3 months.
- •History of intracranial hemorrhage.
- •Intracranial or spinal surgery within 3 months.
- •Known intracranial neoplasm, arteriovenous malformation, large intracranial aneurysm, or other intracranial lesions associated with increased risk of intracranial hemorrhage.
- •Baseline CT showing intracranial hemorrhage, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma.
- •Extensive infarction or significant early ischemic changes on baseline imaging considered unsuitable for intravenous thrombolysis.
- •Severe hepatic dysfunction, severe renal dysfunction, severe infection, active malignancy, terminal illness, or other serious conditions with expected survival <3 months.
- •Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing potential.
- •Unable to complete 90-day follow-up, poor compliance, or other conditions considered unsuitable for study participation by the investigator.
结局指标
主要结局
Excellent Functional Outcome at 90 Days
时间窗: 90 days (±7 days) after treatment
The proportion of participants achieving an excellent functional outcome at 90 days after intravenous recombinant human prourokinase treatment, defined as a modified Rankin Scale (mRS) score of 0-1.
次要结局
- Distribution of Modified Rankin Scale (mRS) Scores at 90 Days(90 days (±7 days) after treatment)
- Functional Independence at 90 Days(90 days (±7 days))
- Barthel Index Score at 90 Days(90 days (±7 days))
- EQ-5D-5L Score at 90 Days(90 days (±7 days))
- Early Neurological Improvement at 24 Hours(24 hours (±6 hours) after treatment)
- Change in NIHSS Score at 24 Hours(24 hours (±6 hours))
- Change in NIHSS Score at 7 Days or Discharge(7 days (±1 day) or discharge)
研究者
Panpan Hu, MD
Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University