Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke
NCT ID: NCT05836740
Last Updated: 2025-05-14
Study Results
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Basic Information
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COMPLETED
PHASE3
1724 participants
INTERVENTIONAL
2023-05-19
2024-08-15
Brief Summary
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Detailed Description
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The primary objective is to evaluate the effect of Minocycline in improving the level of mRS score to 0-1 in patients with moderate to severe acute ischemic stroke within 72 hours of onset.
The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants were interviewed at screening/baseline period, 24±2 hours, 6±1 days, 90±7 days after randomization, and when events occurred.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
In addition, to ensure the blind method, the drug packaging and batch numbers of the two groups are identical, and the packaging batch numbers are uniformly marked.
During the implementation of the study, except for the authorized personnel of the company's supply chain, research management department, and subject security department, members of each research execution group, research center personnel, and CRO data processing personnel cannot view the randomization scheme. The blind method was also used to evaluate the outcome. The participants were randomly divided into groups and blinded to the members of the adjudication committee.
Study Groups
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Minocycline treatment group
Minocycline Hydrochloride Capsules (50 mg per capsule) The first dose should be given immediately after randomization (within 30 minutes); 200mg (4 capsules) for the first dose; Subsequently, 100mg (2 capsules) will be administered once every 12 hours, a total of 9 times (lasting 4.5 days; the subject with dysphagia will be administrated through a nasal feeding tube)
Minocycline hydrochloride capsule
50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
Minocycline placebo-control group
Placebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline) The method of administration was the same as that of treatment group.
Placebo capsules of Minocycline hydrochloride capsules
50 mg per capsule, containing 0mg of Minocycline Hydrochloride.
Interventions
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Minocycline hydrochloride capsule
50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
Placebo capsules of Minocycline hydrochloride capsules
50 mg per capsule, containing 0mg of Minocycline Hydrochloride.
Eligibility Criteria
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Inclusion Criteria
2. Patients with acute ischemic stroke confirmed by CT or MRI within 72 hours of onset;
3. 4≤NIHSS≤25, and Ia≤1;
4. First stroke or mRS 0-1 before the onset of current stroke;
5. Patients or his/her legal representatives are able to understand and sign the informed consent.
Exclusion Criteria
2. Allergic to tetracycline antibiotics or any component of the investigational drug.
3. Known to be resistant to other tetracyclines.
4. Took tetracycline antibiotics within previous one week.
5. Known community-acquired bacterial infection, such as pneumonia or urinary tract infection.
6. History of intracranial hemorrhagic diseases within previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.
7. Intracranial tumors, vascular malformations and other intracranial space-occupying lesions.
8. Rare or unknown etiology of LVO, such as dissection and vasculitis.
9. Severe hepatic insufficiency, renal insufficiency or receiving dialysis before randomization for various reasons (Severe hepatic insufficiency was defined as ALT \>3 times the upper limit of normal value or AST \>3 times the upper limit of normal value; Severe renal insufficiency was defined as creatinine \> 3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate\<30 ml/min/1.73m2).
10. Bleeding tendency (including but not limited to): platelet count \<100×109/L; Administration of oral warfarin and INR\>2; Administration of heparin within previous 48 hours and APTT≥35s; Hereditary bleeding disorders, such as hemophilia.
11. Received any of the following treatments within previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).
12. History of intracranial or spinal surgery within previous 3 months; History of therapeutical surgery or major physical trauma within previous 1 month.
13. Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.
14. Life expectancy of less than 6 months due to advanced stage of comorbidity.
15. Participated in other interventional clinical trials within previous 3 months.
16. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.
18 Years
80 Years
ALL
No
Sponsors
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Neurodawn Pharmaceutical Co., Ltd.
INDUSTRY
Beijing Tiantan Hospital
OTHER
Responsible Party
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yilong Wang
Vice President of Beijing Tiantan Hospital
Principal Investigators
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Yilong Wang, PhD+MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Locations
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The Eighth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Shunyi Hospital
Beijing, Beijing Municipality, China
Chongqing Donghua Hospital
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Shenzhen Hospital, Southern Medical University
Shenzhen, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The Second Nanning People's Hospital
Nanning, Guangxi, China
The Sixth People's Hospital of Hengshui
Hengshui, Hebei, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Dengzhou People's Hospital
Dengzhou, Henan, China
Xiuwu People's Hospital
Jiaozuo, Henan, China
Jiyuan Chinese Medical Hospital
Jiyuan, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
Mengjin People's Hospital
Luoyang, Henan, China
Luoning People's Hospital
Luoyang, Henan, China
Mengzhou People's Hospital
Mengzhou, Henan, China
Nanle Zhongxing Hospital
Puyang, Henan, China
Sui Chinese Medical Hospital
Shangqiu, Henan, China
Xingyang People's Hospital
Zhengzhou, Henan, China
Biyang People's Hospital
Zhumadian, Henan, China
Pingyu People's Hospital
Zhumadian, Henan, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Shimen People's Hospital
Changde, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First People's Hospital of Chenzhou/The First Affiliated Hospital of Xiangnan University
Chenzhou, Hunan, China
Hengyang Central Hospital
Hengyang, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Changzhou Wujin Traditional Chinese Medicine Hospital
Changzhou, Jiangsu, China
Rudong People's Hospital
Nantong, Jiangsu, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Benxi Central Hospital
Benxi, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng Central Hospital
Liaocheng, Shandong, China
The Third People's Hospital of Liaocheng
Liaocheng, Shandong, China
Guanxian People's Hospital
Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, China
Xi'an International Medical Center Hospital
Xi'an, Shannxi, China
Yuci District People's Hospital
Jinzhong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Production and Construction Corps 13 Division Red Star Hospital
Hami, Xinjiang, China
Xinjiang Production&Construction Corps Hospital
Ürümqi, Xinjiang, China
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Tiantan Hospital
Beijing, , China
Ningjin People's Hospital
Dezhou, , China
Zouping City People's Hospital
Jining, , China
Countries
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References
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Other Identifiers
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KY2023-007-01
Identifier Type: -
Identifier Source: org_study_id
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