A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）
NCT ID: NCT05295173
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1412 participants
INTERVENTIONAL
2022-03-21
2023-06-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
NCT04028518
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
NCT05281549
1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients
NCT05395338
Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
NCT05395351
Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
NCT05401149
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
experimental group
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.
Injection of recombinant human tissue plasminogen kinase derivatives
18mg/10ml/stick, provided by Angde Biotech
comparative group
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.
Recombinant human tissue plasminogen activator
20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Injection of recombinant human tissue plasminogen kinase derivatives
18mg/10ml/stick, provided by Angde Biotech
Recombinant human tissue plasminogen activator
20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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;
3. NIHSS score at the time of treatment: from 4 points to 25 points (including 4 points and 25 points);
4. 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;
5. 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).
Exclusion Criteria
2. Weight \>120kg or \<45kg;
3. The timing of stroke symptoms is not known;
4. mRS score before stroke≥ 2 points;
5. NIHSS score 1a (level of consciousness) ≥ 2 points during screening;
6. Patients with intracerebral hemorrhage history;
7. CT/MRI imaging examination shows signs of intracranial hemorrhage or suspected subarachnoid hemorrhage despite CT/MRI imaging findings do not show abnormalities;
8. Severe cerebral trauma or stroke history or other severe traumas within 3 months;
9. Assessment of Intracranial tumor, arteriovenous malformation and aneurysm before admission;
10. Intracranial surgery, intraspinal surgery or other major surgeries within 3 months (based on the assessment of the investigators);
11. Patients with gastrointestinal or urinary system hemorrhage in recent 3 weeks;
12. Active visceral hemorrhage;
13. Assessment or with history of aortic arch dissection before admission;
14. Arterial puncture in 1 week which can not be oppressed;
15. 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;
16. 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;
17. Blood glucose \<50 mg/dl (equivalent to 2.78mmol/L) or \>400 mg/dl (equivalent to 22.2mmol/L);
18. Imaging (CT or MRI)shows large area cerebral infarction;
19. Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
20. Bacterial endocarditis or pericarditis, acute pancreatitis at admission;
21. With history of gastrointestinal ulcers, esophageal varices, aneurysms, or arterial / venous malformations within 3 months before admission;
22. Patients who are unable to cooperate or are unwilling to cooperate with epileptic seizures, or other mental illnesses during stroke episodes;
23. Patients who are ready to go or have undergone endovascular treatment;
24. 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;
25. An expected survival time of no more than 1 year due to other diseases;
26. Patients who are participating in other trials or have participated in other trials within 30 days before randomization;
27. Pregnancy or lactation, or women who have a positive pregnancy test result;
28. The subject who is unsuitable for this study in the opinion of the investigators.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Tiantan Hospital
OTHER
Angde Biotech Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yongjun Wang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, 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
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China
Handan Central Hospital
Handan, Hebei, China
Hengshui People's Hospital
Hengshui, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan Workers'Hospital
Tangshan, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Daqing People's Hospital
Daqing, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang, China
Anyang People's Hospital
Anyang, Henan, 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
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
Nanyang Nanshi Hospital
Nanyang, 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
Wuhan Fourth Hospital (Wuhan Puai Hospital, Wuhan Orthopaedic Hospital)
Wuhan, Hubei, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
Yiyang Central Hospital
Yiyang, Hunan, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 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
Affiliated Hospital of Xuzhou Medical University
Xuzhou, 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
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Yichun People's Hospital
Yichun, 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
Tonghua Central Hospital
Tonghua, Jilin, China
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, 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
Central Hospital Affiliated to Shenyang Medical College
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 Municipality, China
General Hospital of Tongmei Group
Datong, Shanxi, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, China
Xi'an Daxing Hospital
Xi’an, Shanxi, China
Xi'an High-tech Hospital 204 Hospital
Xi’an, Shanxi, China
Zigong First People's Hospital
Zigong, Sichuan, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
First People's Hospital of Kashgar Region
Kashgar, Xinjiang, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wang X, Feng B, Gu HQ, Li Z, Wang Y, Zhao X, Li S, Wang Y. Outcomes of Time to Treatment With Reteplase for Acute Ischemic Stroke: The RAISE Trial Subgroup. JACC Asia. 2025 Apr;5(4):584-592. doi: 10.1016/j.jacasi.2024.12.010. Epub 2025 Feb 11.
Li S, Gu HQ, Li H, Wang X, Jin A, Guo S, Lu G, Che F, Wang W, Wei Y, Wang Y, Li Z, Meng X, Zhao X, Liu L, Wang Y; RAISE Investigators. Reteplase versus Alteplase for Acute Ischemic Stroke. N Engl J Med. 2024 Jun 27;390(24):2264-2273. doi: 10.1056/NEJMoa2400314. Epub 2024 Jun 14.
Li S, Gu HQ, Dai H, Lu G, Wang Y. Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial. Stroke Vasc Neurol. 2024 Nov 5;9(5):568-573. doi: 10.1136/svn-2023-003035.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAD-001-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.