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Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke
Led by Kunming Pharmaceuticals, Inc. · Updated on 2025-12-12
300
Participants Needed
23
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
CONDITIONS
Official Title
Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old, male or female
- Diagnosed with acute ischemic stroke according to Chinese guidelines (2023)
- Stroke symptoms started within 12 hours before screening and drug can start within 12 hours of onset
- NIHSS score between 6 and 24 before intravenous thrombolysis, with limb scores totaling at least 2
- First stroke or good recovery from previous stroke (mRS score 3 before onset)
- Has received or plans to receive standard intravenous thrombolysis treatment
- Able to understand and follow study procedures and sign informed consent
You will not qualify if you...
- Intracranial hemorrhagic diseases confirmed by imaging (e.g., hemorrhagic stroke, hematoma, subarachnoid hemorrhage)
- Received or planning to receive endovascular interventional treatments after stroke onset
- Disturbance of consciousness with NIHSS score Ia >1
- History of intracranial hemorrhage
- History of epilepsy or epileptic symptoms during stroke
- Severe mental illness or conditions affecting neurological tests
- Acute myocardial infarction, cardiac intervention, or severe heart failure within past month
- Malignant tumors or serious diseases with bleeding tendencies and life expectancy under 3 months
- Uncontrolled hypertension despite treatment (systolic 180 mmHg or diastolic 100 mmHg)
- Severe liver impairment or ALT, AST > 2 times upper limit
- Severe kidney impairment or serum creatinine > 1.5 times upper limit
- Use of neuroprotective drugs after stroke onset
- Severe allergies or known allergy to study drug components
- Major surgery within 1 month before screening
- Drug abuse within 3 months before screening
- Participation in other clinical trials within 3 months before this study
- Pregnancy, lactation, or planning pregnancy within 3 months and unwilling to use contraception
- Investigator judgment deeming patient unsuitable for the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 23 locations
1
Beijing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, China
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2
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
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3
Cangzhou Central Hospital
Cangzhou, Hebei, China
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4
Hengshui People's Hospital
Hengshui, Hebei, China
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5
Da Qing Long Nan Hospital
Daqing, Heilongjiang, China
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6
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
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7
The People's Hospital Of Anyang City
Anyang, Henan, China
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8
Nanshi Hospital Of Nanyang
Nanyang, Henan, China
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9
Nanyang Second General Hospital
Nanyang, Henan, China
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10
The First Affiliated Hospital Of Nanyang Medical College
Nanyang, Henan, China
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11
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
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12
Meihakou Central Hospital
Meihekou, Jilin, China
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13
Affiliated Central Hospital Of Shenyang Medical College
Shenyang, Liaoning, China
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14
The First People's Hospital Of Shenyang
Shenyang, Liaoning, China
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15
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China
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16
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
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17
First People's Hospital Of Tancheng
Linyi, Shandong, China
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18
Linyi People's Hospital
Linyi, Shandong, China
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19
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
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20
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
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21
Linfen Central Hospital
Linfen, Shanxi, China
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22
Linfen People's Hospital
Linfen, Shanxi, China
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23
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
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Research Team
D
Duo Gao, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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