A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT05295173
- Lead Sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to assess the efficacy and safety of recombinant human tissue plasminogen kinase derivatives for injection and alteplase in the treatment of patients with acute ischemic stroke within 4.5 hours.
- Detailed Description
This study is a multicenter, randomized, blind endpoint and positive drug control study.
The study plans to recruit 1412 AIS patients within 4.5 hours of onset. Qualified subjects are assigned to the test drug and control drug alteplase group according to the ratio of 1:1. After receiving thrombolytic drugs, the subjects need to carry out a series of safety and effectiveness tests. The mRS score and Barthel index score visits are carried out on the 90th day (± 7 days) after thrombolysis. After the visit, the subjects can leave the group.
In this study, independent blind endpoint evaluators were set up in each research center to evaluate the mRS and Barthel index score 30 and 90 days after thrombolysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1412
- Aged 18 to 80 years（including the critical value);
- Acute ischemic stroke is diagnosed according to the WHO (World Health Organization) stroke diagnostic criteria, the symptoms of acute ischemic stroke are expected to be less than 4.5 hours after the time of acute ischemic stroke which is defined as the last time the patient functions well;
- NIHSS score at the time of treatment: from 4 points to 25 points (including 4 points and 25 points);
- From the signing of informed consent form to 3 months after treatment, fertile men and women of childbearing age should be absent of a birth plan and willing to take effective contraceptive measures;
- Participants who can understand and follow the research process, voluntarily participate, and sign an informed consent form (informed consent is voluntarily signed by the person or legal representative).
- Known to be allergic to research drugs or similar ingredients, or materials used in imaging studies;
- Weight >120kg or <45kg;
- The timing of stroke symptoms is not known;
- mRS score before stroke≥ 2 points;
- NIHSS score 1a (level of consciousness) ≥ 2 points during screening;
- Patients with intracerebral hemorrhage history;
- CT/MRI imaging examination shows signs of intracranial hemorrhage or suspected subarachnoid hemorrhage despite CT/MRI imaging findings do not show abnormalities;
- Severe cerebral trauma or stroke history or other severe traumas within 3 months;
- Assessment of Intracranial tumor, arteriovenous malformation and aneurysm before admission;
- Intracranial surgery, intraspinal surgery or other major surgeries within 3 months (based on the assessment of the investigators);
- Patients with gastrointestinal or urinary system hemorrhage in recent 3 weeks;
- Active visceral hemorrhage;
- Assessment or with history of aortic arch dissection before admission;
- Arterial puncture in 1 week which can not be oppressed;
- Subjects who have an acute bleeding tendency, including but not limited to：1) a platelet count of less than 100 × 109 / L；2) application of low molecular heparin within 24 hours before onset ; 3) Using of thrombin inhibitors or factor Xa inhibitor within 48 hours before onset ; 4) application of oral anticoagulant drugs and with an INR > 1.7 or PT>15s;
- Hypertension remains uncontrolled after active antihypertensive therapy, uncontrolled hypertension refers to a systolic blood pressure >185 mmHg and/or a diastolic blood pressure >110 mmHg;
- Blood glucose <50 mg/dl (equivalent to 2.78mmol/L) or >400 mg/dl (equivalent to 22.2mmol/L);
- Imaging (CT or MRI)shows large area cerebral infarction;
- Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
- Bacterial endocarditis or pericarditis, acute pancreatitis at admission;
- With history of gastrointestinal ulcers, esophageal varices, aneurysms, or arterial / venous malformations within 3 months before admission;
- Patients who are unable to cooperate or are unwilling to cooperate with epileptic seizures, or other mental illnesses during stroke episodes;
- Patients who are ready to go or have undergone endovascular treatment;
- The restricted drug specified in the protocol or any drug that may interfere with the test results must be ingested or desired to continue to be ingested;
- An expected survival time of no more than 1 year due to other diseases;
- Patients who are participating in other trials or have participated in other trials within 30 days before randomization;
- Pregnancy or lactation, or women who have a positive pregnancy test result;
- The subject who is unsuitable for this study in the opinion of the investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description comparative group Recombinant human tissue plasminogen activator Recombinant human tissue plasminogen activator (rt-PA) for injection: 0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h. Subjects should be closely monitored during the treatment period and within 24 hours after administration. experimental group Injection of recombinant human tissue plasminogen kinase derivatives Recombinant human tissue plasminogen kinase derivatives(r-PA) for injection: the first intravenous bolus injection of 18mg, after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time. Subjects were closely monitored during the treatment period and within 24 hours after administration.
- Primary Outcome Measures
Name Time Method Functional handicap on the 90th day after treatment Proportion of patients achieving a Modified Rankin Scale score of 0 to 1 on the 90th day after treatment.
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0-5. A separate category of 6 is usually added for patients who expire. The higher the score, the more severe the stroke.
- Secondary Outcome Measures
Name Time Method Ordinary distribution of mRS scores on the 90th day after treatment Ordinary distribution of mRS scores on the 90th day after treatment.
Proportion of Long-term Improvement on the 90th day after treatment Proportion of patients achieving a mRS of 0 to 2 on the 90th day after treatment.
Barthel Index score on the 90th day after treatment Proportion of patients achieving a Barthel Index score ≥95 on the 90th day after treatment.
The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.Proportion of Neurological Improvement at 24hours and the 7th day after treatment The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline at 24 hours and the 7th day after treatment.
The National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on level of consciousness, eye movements, integrity of visual fields, facial movements,arm and leg muscle strength, sensation, coordination, language,speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
Trial Locations
- Locations (77)
Hengshui People's Hospital
🇨🇳Hengshui, Hebei, China
Anyang People's Hospital
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
🇨🇳Baotou, Inner Mongolia, China
Fukuang General Hospital of Liaoning Health Industry Group
🇨🇳Fushun, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing Emergency Medical Center
🇨🇳Chongqing, Chongqing, China
Gaozhou People's Hospital
🇨🇳Gaozhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
Yue Bei People's Hospital
🇨🇳Shaoguan, Guangdong, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
🇨🇳Cangzhou, Hebei, China
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Handan Central Hospital
🇨🇳Handan, Hebei, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Tangshan Workers'Hospital
🇨🇳Tangshan, Hebei, China
The Third Affiliated Hospital of Qiqihar Medical College
🇨🇳Qiqihar, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Daqing People's Hospital
🇨🇳Daqing, Heilongjiang, China
Jiaozuo People's Hospital
🇨🇳Jiaozuo, Henan, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyan, Henan, China
Nanyang Nanshi Hospital
🇨🇳Nanyang, Henan, China
Luoyang Central Hospital
🇨🇳Luoyang, Henan, China
Nanyang Second People's Hospital
🇨🇳Nanyang, Henan, China
Xinxiang Central Hospital
🇨🇳Xinxiang, Henan, China
Zhengzhou People's Hospital
🇨🇳Zhengzhou, Henan, China
Zhumadian Central Hospital
🇨🇳Zhumadian, Henan, China
The First Affiliated Hospital of Nanhua University
🇨🇳Hengyang, Hunan, China
Wuhan Fourth Hospital (Wuhan Puai Hospital, Wuhan Orthopaedic Hospital)
🇨🇳Wuhan, Hubei, China
Yiyang Central Hospital
🇨🇳Yiyang, Hunan, China
Inner Mongolia Baogang Hospital
🇨🇳Baotou, Inner Mongolia, China
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Inner Mongolia Autonomous Region People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Huai'an Second People's Hospital
🇨🇳Huai'an, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Ganzhou People's Hospital
🇨🇳Ganzhou, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Yichun People's Hospital
🇨🇳Yichun, Jiangxi, China
Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jilin People's Hospital
🇨🇳Jilin, Jilin, China
Meihekou Central Hospital
🇨🇳Meihekou, Jilin, China
Jilin Guowen Hospital
🇨🇳Siping, Jilin, China
First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
PLA Northern Theater Command General Hospital
🇨🇳Shenyang, Liaoning, China
Shenyang First People's Hospital
🇨🇳Shenyang, Liaoning, China
Dezhou People's Hospital
🇨🇳Dezhou, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shandong Qianfo Mountain Hospital
🇨🇳Jinan, Shandong, China
Affiliated Hospital of Jining Medical College
🇨🇳Jining, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Tai'an Central Hospital
🇨🇳Tai'an, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
🇨🇳Weifang, Shandong, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Shanghai Pudong Hospital
🇨🇳Shanghai, Shanghai, China
General Hospital of Tongmei Group
🇨🇳Datong, Shanxi, China
Xi'an Daxing Hospital
🇨🇳Xi'an, Shanxi, China
Xi'an High-tech Hospital 204 Hospital
🇨🇳Xi'an, Shanxi, China
Yan'an University Xianyang Hospital
🇨🇳Xianyang, Shanxi, China
Zigong First People's Hospital
🇨🇳Zigong, Sichuan, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
First People's Hospital of Kashgar Region
🇨🇳Kashgar, Xinjiang, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
Jiaxing First Hospital
🇨🇳Jiaxing, Zhejiang, China
Taizhou First People's Hospital
🇨🇳Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Tonghua Central Hospital
🇨🇳Tonghua, Jilin, China