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This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment (TOAST )classification.
A comprehensive evaluation of commonly used clinical neuroprotective drugs was conducted, analyzing their practical application value in acute ischemic stroke treatment across six dimensions: safety, efficacy, cost-effectiveness, innovation, appropriateness, and accessibility. In a real-world clinical setting, this prospective observational study design primarily evaluates the association between edaravone and dexrazoxane usage and the efficacy and safety outcomes in patients with mild-to-moderate ischemic stroke, while conducting subgroup analyses based on different Trial of Org 10172 in Acute Stroke Treatment (TOAST )classifications.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Modified Rankin Scale(mRS )scores of 0-1 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS scores of 0-2 | 30 days | |
| Percentage reduction in National Institutes of Health Stroke Scale (NIHSS )score compared to pre-treatment | 90 days after medication |
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Inclusion Criteria:
1: Age≥18
2: Acute ischemic stroke in the anterior circulation occurring within 48 hours
3: Baseline NIHSS score of 1-15 points (mild stroke: baseline NIHSS score of 1-5 points; moderate stroke: baseline NIHSS score of 6-15 points)
4: Pre-onset mRS score≤1
5: Use of Edaravone (injection or tablets)
6: Exclude intracranial hemorrhage
7: Sign the informed consent form
Exclusion Criteria:
1: A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease
2: Patients with cerebral embolism or suspected cerebral embolism who also have severe atrioventricular block, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, or a heart rate below 50 beats per minute
3: Abnormal liver function (ALT or AST transaminase levels exceeding the upper limit of normal), abnormal kidney function (creatinine levels exceeding the upper limit of normal), or individuals with other severe systemic diseases, etc
4: Allergy to the test drug
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Patients with ischemic stroke
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li | Contact | 13791126823 | li_xyan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofang Niu | Heze Municipal Hospital | Principal Investigator |
| Leqing Zhang | Yanggu County People's Hospital | Principal Investigator |
| Lei Duan |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38372981 | Result | Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Zibo Central Hospital |
| Principal Investigator |
| Kai Ren | Haiyang People's Hospital | Principal Investigator |
| Rongrong Zhang | Sishui County People's Hospital | Principal Investigator |
| Ping Yang | Jinan Fourth People's Hospital | Principal Investigator |
| Ning Liu | Shandong Hospital of Integrated Traditional Chinese and Western Medicine | Principal Investigator |
| Pengcheng Du | Qilu Hospital of Shandong University, Dezhou Branch | Principal Investigator |
| Hui Liu | Jinan Municipal People's Hospital | Principal Investigator |
| Xi Rong | Weifang Yidu Central Hospital | Principal Investigator |
| Deyin Zhai | Linyi Traditional Chinese Medicine Hospital | Principal Investigator |
| Zhiqiang Zhang | Anqiu People's Hospital | Principal Investigator |
| Jiyong Wu | Shandong Provincial Hospital | Principal Investigator |
| Meixia Wang | Jining Medical University Affiliated Hospital | Principal Investigator |
| Ping Wang | Liaocheng People's Hospital | Principal Investigator |
| Jiyao Li | Liaocheng Municipal People's Hospital | Principal Investigator |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |