Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis

Prior treatment

• mRS score ≥ 2 prior to onset of the current stroke;
• Presence of a known community-acquired bacterial infection (e.g., pneumonia, urinary tract infection) or any other concurrent infection requiring antibiotic treatment;
• Use of tretinoin, androgen or antiandrogen treatment (e.g., anabolic steroids, spironolactone) within the past 3 months;

Other illness

• History of pseudomembranous colitis or antibiotic-associated colitis;
• Known allergy or intolerance to tetracycline antibiotics or any component of minocycline;
• History of intracranial hemorrhagic disease within the past 3 months, for example, parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma.
• Malformation, tumor, abscess, or other major non-ischaemic brain diseases (e.g., multiple sclerosis, other intracranial space-occupying lesions) on baseline cranial CT or MRI;
• History of systemic lupus erythematosus;
• Presence of a severe non-cardio-cerebrovascular disease with a life expectancy of less than 6 months;
• Any other condition that is not suitable for participating in this clinical trial, such as inability to understand or follow the study procedures due to physical, cognitive, emotional, or mental disorders.

Lab values

• Known severe hepatic insufficiency (ALT or AST \> 3 times of the upper limit of normal), severe renal insufficiency (creatinine \> 3.0 mg/dL \[265.2 μmol/L\], estimated glomerular filtration rate \<30 mL/min/1.73m², or have received dialysis before randomization);

Other

• Known resistance to other tetracyclines;
• Use of tetracycline antibiotics within the past 7 days;
• Rare or unknown etiology of large vessel occlusion (e.g., arterial dissection, vasculitis);
• Pregnant, breastfeeding, or of childbearing potential who are unwilling to use effective contraception throughout the study;
• Participation in any other clinical trial within the past 30 days;

• Age between 18 and 80 years;
• Patients with acute ischaemic stroke confirmed by CT or MRI;
• Having received or planning to receive intravenous thrombolysis within 4.5 hours of onset or within an extended window of 4.5-24 hours based on guideline recommendations (The intravenous thrombolytic drugs include: alteplase, tenecteplase, reteplase or recombinant human prourokinase);
• The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
• 6≤NIHSS≤25, and Ia≤1;
• Signed informed consent.