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
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baotou Central Hospital Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Beijing Shunyi Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Tiantan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Eighth Medical Center of PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Benxi Central Hospital Coordinator of this site? Confirm its status | Benxi | China | Unknown status |
| China-Japan Union Hospital of JiLin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Shimen People's Hospital Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Changzhou Wujin Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First People's Hospital of Chenzhou/The First Affiliated Hospital of Xiangnan University Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| Chongqing Donghua Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Dengzhou People's Hospital Coordinator of this site? Confirm its status | Dengzhou | China | Unknown status |
| Ningjin People's Hospital Coordinator of this site? Confirm its status | Dezhou | China | Unknown status |
| Xinjiang Production and Construction Corps 13 Division Red Star Hospital Coordinator of this site? Confirm its status | Hami | China | Unknown status |
| Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Sixth People's Hospital of Hengshui Coordinator of this site? Confirm its status | Hengshui | China | Unknown status |
| Hengyang Central Hospital Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| Xiuwu People's Hospital Coordinator of this site? Confirm its status | Jiaozuo | China | Unknown status |
| Zouping City People's Hospital Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Yuci District People's Hospital Coordinator of this site? Confirm its status | Jinzhong | China | Unknown status |
| The First Affiliated Hospital of Jinzhou Medical University Coordinator of this site? Confirm its status | Jinzhou | China | Unknown status |
| Jiujiang University Affiliated Hospital Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| Jiyuan Chinese Medical Hospital Coordinator of this site? Confirm its status | Jiyuan | China | Unknown status |
| Guanxian People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| The Third People's Hospital of Liaocheng Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Liaocheng Central Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Linfen Central Hospital Coordinator of this site? Confirm its status | Linfen | China | Unknown status |
| Luoning People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Mengjin People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Mengzhou People's Hospital Coordinator of this site? Confirm its status | Mengzhou | China | Unknown status |
| The Second Nanning People's Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Rudong People's Hospital Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Nanle Zhongxing Hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Pudong New Area Gongli Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Sui Chinese Medical Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Unknown status |
| Shenzhen Hospital, Southern Medical University Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen Second People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Fourth Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| North China University of Science and Technology Affiliated Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| Tianjin Xiqing Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Huanhu Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Xinjiang Production&Construction Corps Hospital Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Weihai Wendeng District People's Hospital Coordinator of this site? Confirm its status | Weihai | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xi'an International Medical Center Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Xingyang People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Pingyu People's Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| Biyang People's Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| Zibo Central hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.