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Acute Ischemic StrokePhase 3NCT05295173

A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）

A Phase 3 study testing Injection of recombinant human tissue plasminogen kinase derivatives and Recombinant human tissue plasminogen activator in people with Acute Ischemic Stroke, run by Angde Biotech Pharmaceutical Co., Ltd. at 78 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Injection of recombinant human tissue plasminogen kinase derivatives and Recombinant human tissue plasminogen activator
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,412 participants
Where
78 sitesChina
Study dates
21 Mar 2022to 22 Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
Show all 28Show fewer
  • 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.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

China78 sites

  • Anyang People's Hospital

    Anyang, Henan, 456550

  • Inner Mongolia Baogang Hospital

    Baotou, Inner Mongolia, 014010

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia, 014017

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100071

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233070

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061000

  • Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    Cangzhou, Hebei, 061007

  • First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality, 400014

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163711

  • General Hospital of Tongmei Group

    Datong, Shanxi, 037021

  • Dezhou People's Hospital

    Dezhou, Shandong, 253014

  • Fukuang General Hospital of Liaoning Health Industry Group

    Fushun, Liaoning, 113012

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341001

  • Gaozhou People's Hospital

    Gaozhou, Guangdong, 525299

  • Handan Central Hospital

    Handan, Hebei, 056002

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Hengshui People's Hospital

    Hengshui, Hebei, 053000

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan, 421000

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010010

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu, 223002

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

  • Jiaozuo People's Hospital

    Jiaozuo, Henan, 454002

  • Jiaxing First Hospital

    Jiaxing, Zhejiang, 314001

  • Jilin People's Hospital

    Jilin City, Jilin, 132000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shandong Qianfo Mountain Hospital

    Jinan, Shandong, 250014

  • Affiliated Hospital of Jining Medical College

    Jining, Shandong, 272007

  • First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121004

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475001

  • First People's Hospital of Kashgar Region

    Kashgar, Xinjiang, 844099

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252037

  • Linyi People's Hospital

    Linyi, Shandong, 276004

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyan, Henan, 471003

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Luoyang Central Hospital

    Luoyang, Henan, 471006

  • Meihekou Central Hospital

    Meihekou, Jilin, 135099

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • Nanyang Nanshi Hospital

    Nanyang, Henan, 473006

  • Nanyang Second People's Hospital

    Nanyang, Henan, 474599

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337005

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • The Third Affiliated Hospital of Qiqihar Medical College

    Qiqihar, Heilongjiang, 161099

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality, 201399

  • Yue Bei People's Hospital

    Shaoguan, Guangdong, 512026

  • PLA Northern Theater Command General Hospital

    Shenyang, Liaoning, 110000

  • Shenyang First People's Hospital

    Shenyang, Liaoning, 110000

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110075

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050004

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050030

  • Jilin Guowen Hospital

    Siping, Jilin, 136199

  • Tai'an Central Hospital

    Tai’an, Shandong, 271099

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, 318020

  • Tangshan Workers'Hospital

    Tangshan, Hebei, 063007

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • Tonghua Central Hospital

    Tonghua, Jilin, 134099

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • Weifang Hospital of Traditional Chinese Medicine

    Weifang, Shandong, 261041

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

  • Wuhan Fourth Hospital (Wuhan Puai Hospital, Wuhan Orthopaedic Hospital)

    Wuhan, Hubei, 430030

  • Xi'an Daxing Hospital

    Xi’an, Shanxi, 710016

  • Xi'an High-tech Hospital 204 Hospital

    Xi’an, Shanxi, 710065

  • Yan'an University Xianyang Hospital

    Xianyang, Shanxi, 712099

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453099

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221399

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

  • Yichun People's Hospital

    Yichun, Jiangxi, 336099

  • Yiyang Central Hospital

    Yiyang, Hunan, 413099

  • Zhengzhou People's Hospital

    Zhengzhou, Henan, 450002

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, 519099

  • Zhumadian Central Hospital

    Zhumadian, Henan, 463000

  • Zigong First People's Hospital

    Zigong, Sichuan, 643099

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
Injection of recombinant human tissue plasminogen kinase derivatives, Recombinant human tissue plasminogen activator
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of recombinant human tissue plasminogen kinase derivativesDrug

    Also called Reteplase, brand name: Ruitongli, r-PA

    18mg/10ml/stick, provided by Angde Biotech

  • Recombinant human tissue plasminogen activatorDrug

    Also called Alteplase, brand name: Actilyse, rt-PA

    20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.

Study groups in NCT05295173
Study groupRoleWhat they receive
experimental groupExperimentalRecombinant 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.
Receives: Drug: Injection of recombinant human tissue plasminogen kinase derivatives
comparative groupActive 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.
Receives: Drug: Recombinant human tissue plasminogen activator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: on the 90th day after treatment

Secondary outcomes (4)

  1. Proportion of Neurological Improvement

    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).

    Measured: at 24hours and the 7th day after treatment

  2. Proportion of Long-term Improvement

    Proportion of patients achieving a mRS of 0 to 2 on the 90th day after treatment.

    Measured: on the 90th day after treatment

  3. Ordinary distribution of mRS scores

    Ordinary distribution of mRS scores on the 90th day after treatment.

    Measured: on the 90th day after treatment

  4. Barthel Index score

    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.

    Measured: on the 90th day after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start21 Mar 2022
  3. Primary completion22 Jun 2023
  4. Study completion22 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295173
Sponsor's protocol ID
CRAD-001-03
Status last verified
Mar 2024
First submitted
24 Feb 2022
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang J, He D, Gu H, Li Z, Wang Y, Zhao X, Wang Y, Li S. Efficacy and Safety of Reteplase Versus Alteplase in Acute Ischemic Stroke Based on Fibrinogen Levels: The RAISE Trial Subgroup. J Am Heart Assoc. 2026 May 19;15(10):e047832. doi: 10.1161/JAHA.125.047832. Epub 2026 May 6.

    PubMed 42089199

  • 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.

    PubMed 40180551

  • 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.

    PubMed 38884332

  • 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.

    PubMed 38286482

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Injection of recombinant human tissue plasminogen kinase derivatives and Recombinant human tissue plasminogen activator in people with Acute Ischemic Stroke, run by Angde Biotech Pharmaceutical Co., Ltd. at 78 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional handicap (time frame: on the 90th day after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295173, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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