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NCT05836740CompletedPhase 3

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial

Source: ClinicalTrials.gov · Last updated 14 May 2025

Brief summary (registry, in English)

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1724 (actual)
First submitted
19 Apr 2023
Start date
19 May 2023
Primary completion date
20 May 2024
Lead sponsor
Beijing Tiantan Hospital
Diseases
Stroke
NCT number
NCT05836740

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1724
  • From 19 May 2023 to the primary completion date, 20 May 2024
  • 58 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Allergic to tetracycline antibiotics or any component of the investigational drug.
  • Took tetracycline antibiotics within previous one week.
  • History of intracranial hemorrhagic diseases within previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.
  • Received any of the following treatments within previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).
  • History of intracranial or spinal surgery within previous 3 months; History of therapeutical surgery or major physical trauma within previous 1 month.
  • Participated in other interventional clinical trials within previous 3 months.

Other illness

  • History of pseudomembranous colitis or antibiotic-related colitis.
  • Known community-acquired bacterial infection, such as pneumonia or urinary tract infection.
  • 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.

Lab values

  • 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).
  • 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.

Age

  • Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.

Other

  • Known to be resistant to other tetracyclines.
  • Intracranial tumors, vascular malformations and other intracranial space-occupying lesions.
  • Rare or unknown etiology of LVO, such as dissection and vasculitis.
  • Life expectancy of less than 6 months due to advanced stage of comorbidity.

Who the study is looking for

  • 18≤Age≤80 years old;
  • Patients with acute ischemic stroke confirmed by CT or MRI within 72 hours of onset;
  • 4≤NIHSS≤25, and Ia≤1;
  • First stroke or mRS 0-1 before the onset of current stroke;
  • Patients or his/her legal representatives are able to understand and sign the informed consent.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baotou Central Hospital
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BaotouChinaUnknown status
Beijing Shunyi Hospital
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BeijingChinaUnknown status
Beijing Tiantan Hospital
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BeijingChinaUnknown status
The Eighth Medical Center of PLA General Hospital
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BeijingChinaUnknown status
Benxi Central Hospital
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BenxiChinaUnknown status
China-Japan Union Hospital of JiLin University
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ChangchunChinaUnknown status
Shimen People's Hospital
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ChangdeChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Changzhou Wujin Traditional Chinese Medicine Hospital
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ChangzhouChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
The First People's Hospital of Chenzhou/The First Affiliated Hospital of Xiangnan University
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ChenzhouChinaUnknown status
Chongqing Donghua Hospital
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ChongqingChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Dengzhou People's Hospital
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DengzhouChinaUnknown status
Ningjin People's Hospital
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DezhouChinaUnknown status
Xinjiang Production and Construction Corps 13 Division Red Star Hospital
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HamiChinaUnknown status
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine
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HangzhouChinaUnknown status
The Sixth People's Hospital of Hengshui
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HengshuiChinaUnknown status
Hengyang Central Hospital
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HengyangChinaUnknown status
Xiuwu People's Hospital
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JiaozuoChinaUnknown status
Zouping City People's Hospital
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JiningChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
Yuci District People's Hospital
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JinzhongChinaUnknown status
The First Affiliated Hospital of Jinzhou Medical University
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JinzhouChinaUnknown status
Jiujiang University Affiliated Hospital
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JiujiangChinaUnknown status
Jiyuan Chinese Medical Hospital
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JiyuanChinaUnknown status
Guanxian People's Hospital
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LiaochengChinaUnknown status
The Third People's Hospital of Liaocheng
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LiaochengChinaUnknown status
Liaocheng Central Hospital
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LiaochengChinaUnknown status
Linfen Central Hospital
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LinfenChinaUnknown status
Luoning People's Hospital
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LuoyangChinaUnknown status
Mengjin People's Hospital
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LuoyangChinaUnknown status
Luoyang Central Hospital
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LuoyangChinaUnknown status
Mengzhou People's Hospital
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MengzhouChinaUnknown status
The Second Nanning People's Hospital
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NanningChinaUnknown status
Rudong People's Hospital
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NantongChinaUnknown status
Nanle Zhongxing Hospital
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PuyangChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Shanghai Pudong New Area Gongli Hospital
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ShanghaiChinaUnknown status
Sui Chinese Medical Hospital
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ShangqiuChinaUnknown status
Shenzhen Hospital, Southern Medical University
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ShenzhenChinaUnknown status
Shenzhen Second People's Hospital
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ShenzhenChinaUnknown status
The Fourth Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
First Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
North China University of Science and Technology Affiliated Hospital
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TangshanChinaUnknown status
Tianjin Xiqing Hospital
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TianjinChinaUnknown status
Tianjin Huanhu Hospital
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TianjinChinaUnknown status
Xinjiang Production&Construction Corps Hospital
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ÜrümqiChinaUnknown status
Weihai Wendeng District People's Hospital
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WeihaiChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Wuhan NO.1 Hospital
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WuhanChinaUnknown status
Xi'an International Medical Center Hospital
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Xi'anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
Xingyang People's Hospital
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ZhengzhouChinaUnknown status
Pingyu People's Hospital
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ZhumadianChinaUnknown status
Biyang People's Hospital
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ZhumadianChinaUnknown status
Zibo Central hospital
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ZiboChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.