rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window (SIMPLIFIED)
2026年6月11日 更新者：Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study.
It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).
研究概览
地位
招聘中
条件
详细说明
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study with a target enrollment of at least 750 patients.
The trial focuses on individuals with acute ischemic stroke (AIS) presenting within a 4.5 to 24-hour window who are not planned for endovascular thrombectomy (EVT).
Patients meeting simplified imaging criteria based on non-contrast CT (NCCT) are randomized 1:1 to receive a single intravenous bolus of 0.25 mg/kg tenecteplase (TNK) or standard medical treatment.
The primary outcome is the 90-day excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1.
Safety outcomes include symptomatic intracranial hemorrhage (sICH) and 90-day mortality.
研究类型
介入性
注册 (估计的)
750
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jinyuan Wang
- 电话号码：86-18558992193
- 邮箱：wangjy257@mail2.sysu.edu.cn
研究联系人备份
- 姓名：Xinguang Yang, MD, PhD
- 邮箱：yangxinguang0926@163.com
学习地点
-
-
-
Guangzhou、中国、510120
- 招聘中
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
-
接触：
- Jinyuan Wang
- 电话号码：86-20-81332619
- 邮箱：wangjy257@mail2.sysu.edu.cn
-
接触：
- Xinguang Yang, MD, PhD
- 邮箱：yangxinguang0926@163.com
-
首席研究员：
- Yamei Tang, MD, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18 years or older.
- Presumed acute ischemic stroke of the anterior circulation.
- Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
- Limited early ischemic changes on non-contrast CT (NCCT).
- Written informed consent signed by patients or their legally authorized representatives.
Exclusion Criteria:
- Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
- Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
- Endovascular thrombectomy (EVT) planned at the time of randomization.
- Pre-stroke mRS≥2.
- Allergy to the test drug and its ingredients.
- Severe head trauma or ischemic stroke in the last 3 months.
- Intracranial or intraspinal surgery within 3 months before enrollment.
- Intracranial tumor or large-size aneurysm found before enrollment.
- Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
- Active visceral bleeding.
- Aortic arch dissection confirmed by examination or medical history.
- Infective endocarditis confirmed by examination or medical history.
- Platelet count less than 100 × 109 /L.
- Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
- Pregnant or lactating women.
- Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening.
- Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management.
- Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
- Participating in other trials.
- Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention Arm
Intravenous tenecteplase
|
Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization.
|
|
有源比较器：Control Arm
Standard medical treatment
|
Patients in the control arm will receive standard medical treatment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Excellent functional outcome
大体时间：at 90 (±14) days
|
The proportion of mRS score 0-1 at 90 (±14) days.
|
at 90 (±14) days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ordinal distribution of mRS
大体时间：at 90 (±14) days
|
The proportion of mRS distribution at 90 (±14) days
|
at 90 (±14) days
|
|
Favorable functional outcome
大体时间：at 90 (±14) days
|
The proportion of mRS score 0-2 at 90 (±14) days
|
at 90 (±14) days
|
|
Change in NIHSS Score at 24 (±12) hours
大体时间：at 24 (±12) hours
|
NIHSS score change from baseline at 24 (±12) hours
|
at 24 (±12) hours
|
|
Change in NIHSS Score at 7 (±1) days or discharge
大体时间：at 7 (±1) days or discharge
|
NIHSS score change from baseline at 7 (±1) days or discharge
|
at 7 (±1) days or discharge
|
|
Quality of life (EQ-5D-5L)
大体时间：at 90 (±14) days
|
Quality of life measured by EQ-5D-5L at 90 (±14) days
|
at 90 (±14) days
|
|
Symptomatic intracranial hemorrhage
大体时间：within 36 hours
|
Symptomatic intracranial hemorrhage (sICH) within 36 hours from randomization (SITS-MOST criteria)
|
within 36 hours
|
|
Any intracranial hemorrhage
大体时间：within 36 hours
|
Any intracranial hemorrhage within 36 hours
|
within 36 hours
|
|
Major extracranial bleeding
大体时间：within 36 hours
|
Major extracranial bleeding within 36 hours (GUSTO criteria: moderate and severe bleeding)
|
within 36 hours
|
|
Mortality
大体时间：within 90 days
|
All-cause mortality within 90 days
|
within 90 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yamei Tang, MD, PhD、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年4月22日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SYSKY-2026-479-02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
IPD 共享时间框架
6 months after the trial completion.
IPD 共享访问标准
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.