A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）
A Phase III, Multicenter, Randomized, Blind Endpoint and Positive Drug Control Study of Recombinant Human Tissue Plasminogen Kinase Derivatives for Injection in the Treatment of Patients With Acute Ischemic Stroke
1 other identifier
interventional
1,412
1 country
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Shorter than P25 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2023
CompletedMarch 4, 2024
March 1, 2024
1.3 years
February 24, 2022
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Functional handicap
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.
on the 90th day after treatment
Secondary Outcomes (4)
Proportion of Neurological Improvement
at 24hours and the 7th day after treatment
Proportion of Long-term Improvement
on the 90th day after treatment
Ordinary distribution of mRS scores
on the 90th day after treatment
Barthel Index score
on the 90th day after treatment
Other Outcomes (4)
Proportion of subjects died of all cause
within 7 days and 90 days after treatment
Percentage of subjects with symptomatic intracranial hemorrhage (sICH)
SITS criteria: within 36 hours after treatment; ECASS III criteria: within 36 hours and 7 days after treatment
Proportion of subjects with major hemorrhage and clinically relevant non-major hemorrhage（ISTH criteria）
within 90 days after treatment
- +1 more other outcomes
Study Arms (2)
experimental group
EXPERIMENTALRecombinant 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.
comparative group
ACTIVE COMPARATORRecombinant 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.
Interventions
18mg/10ml/stick, provided by Angde Biotech
20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angde Biotech Pharmaceutical Co., Ltd.lead
- Beijing Tiantan Hospitalcollaborator
Study Sites (78)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233070, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, 400014, China
Gaozhou People's Hospital
Gaozhou, Guangdong, 525299, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Meizhou People's Hospital
Meizhou, Guangdong, 514000, China
Yue Bei People's Hospital
Shaoguan, Guangdong, 512026, China
Zhuhai People's Hospital
Zhuhai, Guangdong, 519099, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, 061007, China
Handan Central Hospital
Handan, Hebei, 056002, China
Hengshui People's Hospital
Hengshui, Hebei, 053000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050004, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030, China
Tangshan Workers'Hospital
Tangshan, Hebei, 063007, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
Daqing People's Hospital
Daqing, Heilongjiang, 163711, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The Third Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang, 161099, China
Anyang People's Hospital
Anyang, Henan, 456550, China
Jiaozuo People's Hospital
Jiaozuo, Henan, 454002, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyan, Henan, 471003, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Luoyang Central Hospital
Luoyang, Henan, 471006, China
Nanyang Nanshi Hospital
Nanyang, Henan, 473006, China
Nanyang Second People's Hospital
Nanyang, Henan, 474599, China
Xinxiang Central Hospital
Xinxiang, Henan, 453099, China
Zhengzhou People's Hospital
Zhengzhou, Henan, 450002, China
Zhumadian Central Hospital
Zhumadian, Henan, 463000, China
Wuhan Fourth Hospital (Wuhan Puai Hospital, Wuhan Orthopaedic Hospital)
Wuhan, Hubei, 430030, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, 421000, China
Yiyang Central Hospital
Yiyang, Hunan, 413099, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 014010, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 014017, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010010, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223002, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221399, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337005, China
Yichun People's Hospital
Yichun, Jiangxi, 336099, China
First Hospital of Jilin University
Changchun, Jilin, 130021, China
Jilin People's Hospital
Jilin, Jilin, 132000, China
Meihekou Central Hospital
Meihekou, Jilin, 135099, China
Jilin Guowen Hospital
Siping, Jilin, 136199, China
Tonghua Central Hospital
Tonghua, Jilin, 134099, China
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, 113012, China
First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121004, China
PLA Northern Theater Command General Hospital
Shenyang, Liaoning, 110000, China
Shenyang First People's Hospital
Shenyang, Liaoning, 110000, China
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110075, China
Dezhou People's Hospital
Dezhou, Shandong, 253014, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Qianfo Mountain Hospital
Jinan, Shandong, 250014, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, 272007, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252037, China
Linyi People's Hospital
Linyi, Shandong, 276004, China
Qingdao Central Hospital
Qingdao, Shandong, 266042, China
Tai'an Central Hospital
Tai’an, Shandong, 271099, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399, China
General Hospital of Tongmei Group
Datong, Shanxi, 037021, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, 712099, China
Xi'an Daxing Hospital
Xi’an, Shanxi, 710016, China
Xi'an High-tech Hospital 204 Hospital
Xi’an, Shanxi, 710065, China
Zigong First People's Hospital
Zigong, Sichuan, 643099, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
First People's Hospital of Kashgar Region
Kashgar, Xinjiang, 844099, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
Jiaxing First Hospital
Jiaxing, Zhejiang, 314001, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015, China
Related Publications (3)
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.
PMID: 40180551DERIVEDLi 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.
PMID: 38884332DERIVEDLi 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.
PMID: 38286482DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongjun Wang
Beijing Tiantan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 25, 2022
Study Start
March 21, 2022
Primary Completion
June 22, 2023
Study Completion
June 22, 2023
Last Updated
March 4, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share