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

NCT05295173
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,412
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Lead sponsor
Angde Biotech Pharmaceutical Co., Ltd.
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Start date
2022-03-21
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Number of sites
78
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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.
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Short title
A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-06-22
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First posted
2022-03-25
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Registry last updated
2024-03-04
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Primary completion date
2023-06-22
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Start date
2022-03-21
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Actual participants
1,412
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Participants
1,412
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Participant count basis
Actual
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Protocol amendments
3
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Randomisation ratio
1:1
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Number of sites
78
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Angde Biotech Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05295173
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ClinicalTrials.gov ID
NCT05295173
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Functional handicap

    Timeframe: 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.

  1. Proportion of Neurological Improvement

    Timeframe: 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).

  2. Proportion of Long-term Improvement

    Timeframe: on the 90th day after treatment

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

  3. Ordinary distribution of mRS scores

    Timeframe: on the 90th day after treatment

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

  4. Barthel Index score

    Timeframe: 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.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  1. Aged 18 to 80 years（including the critical value);
  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).

  1. Known to be allergic to research drugs or similar ingredients, or materials used in imaging studies;
  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.
Sources for eligibility
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  • The First Affiliated Hospital of Bengbu Medical CollegeBengbu, China
  • Xuanwu Hospital of Capital Medical UniversityBeijing, China
  • Beijing Tiantan HospitalBeijing, China
  • Chongqing Emergency Medical CenterChongqing, China
  • Gaozhou People's HospitalGaozhou, China
  • Jiangmen Central HospitalJiangmen, China
  • Meizhou People's HospitalMeizhou, China
  • Yue Bei People's HospitalShaoguan, China
  • Zhuhai People's HospitalZhuhai, China
  • Cangzhou Central HospitalCangzhou, China
  • Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineCangzhou, China
  • Handan Central HospitalHandan, China
  • Hengshui People's HospitalHengshui, China
  • The Second Hospital of Hebei Medical UniversityShijiazhuang, China
  • The First Hospital of Hebei Medical UniversityShijiazhuang, China
  • Tangshan Workers'HospitalTangshan, China
  • Daqing Oilfield General HospitalDaqing, China
  • Daqing People's HospitalDaqing, China
  • The Fourth Affiliated Hospital of Harbin Medical UniversityHarbin, China
  • The Third Affiliated Hospital of Qiqihar Medical CollegeQiqihar, China
  • Anyang People's HospitalAnyang, China
  • Jiaozuo People's HospitalJiaozuo, China
  • Huaihe Hospital of Henan UniversityKaifeng, China
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyan, China
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, China

And 53 more, listed on the interactive page.

Sources for sites
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Sources for references
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Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (2)