NCT04797013已完成3 期
A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial
Beijing Tiantan Hospital61 个研究点 分布在 1 个国家目标入组 1,430 人开始时间: 2021年6月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,430
- 试验地点
- 61
- 主要终点
- Excellent functional outcome
研究概览
简要总结
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
详细描述
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.
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
- Single (Outcomes Assessor)
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
- •Age ≥18 years old, no gender limitation;
- •The time from onset to treatment was < 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
- •The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- •MRS before onset was 0-1 points
- •Baseline NIHSS 5-25(both included);
- •Informed consent from the patient or surrogate.
排除标准
- •Intended to proceed endovascular treatment;
- •NIHSS consciousness score >2;
- •Allergy to tenecteplase or alteplase;
- •Past history of intracranial hemorrhage ;
- •A history of severe head trauma or stroke within 3 months;
- •A history of intracranial or spinal surgery within 3 months;
- •A history of gastrointestinal or urinary bleeding within 3 weeks;
- •2 weeks of major surgery;
- •Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
- •Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
- •Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- •Active visceral bleeding;
- •Aortic arch dissection was found;
- •After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
- •Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- •Blood glucose <2.8 mmol/L or >22.22 mmol/L;
- •Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
- •Heparin treatment was received within 24 h;
- •Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
- •Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
- •Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
- •Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
- •Participation in other clinical trials within 3 months prior to screening;
- •Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
研究组 & 干预措施
rhTNK-tPA (0.25mg/kg)
Active Comparator
rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
干预措施: rhTNK-tPA (Drug)
rt-PA (0.9mg/kg)
Active Comparator
10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
干预措施: rt-PA (Drug)
结局指标
主要结局
Excellent functional outcome
时间窗: 90 days
Proportion of subjects with mRS(0-1) at 90 days.
次要结局
- National Institutes of Health Stroke Scale (NIHSS)(24 hours，day7)
- Barthel (BI)(90 days)
- Good functional outcome(90 days)
- Modified Rankin Scale(mRS)(90 days)
- EQ-5D(90 days)
研究者
Yongjun Wang
President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Beijing Tiantan Hospital
研究点 (61)
Loading locations...
相似试验
招募中
3 期
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer SubjectsBreast CancerNCT06079983Jiangsu Alphamab Biopharmaceuticals Co., Ltd400
已完成
3 期
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the PancreasPancreatic Cancer MetastaticNCT03504423Cornerstone Pharmaceuticals528
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsSCLCEUCTR2021-004606-21-HUAstraZeneca AB1,000
招募中
3 期
Study of Datopotamab Deruxtecan (Dato-DXd) for first line treatment of patients with locally advanced or metastatic NSCLCCTRI/2023/05/052218AstraZeneca AB
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)SCLCEUCTR2021-004606-21-ATAstraZeneca AB1,280