Minocycline Hydrochloride Capsule (50 mg per capsule)Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline)
Minocycline Hydrochloride Capsule (50 mg per capsule): A loading dose of 200 mg will be administered before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis, followed by a maintenance dose of 100 mg every 12 hours for the subsequent 4 days.
A total of 9 times will be administered over a period of 4.5 days. Minocycline hydrochloride capsules will be administered orally or via a nasogastric feeding tube if the participant has dysphagia.
Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline): A loading dose of 200 mg will be administered before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis, followed by a maintenance dose of 100 mg every 12 hours for the subsequent 4 days.
A total of 9 times will be administered over a period of 4.5 days. Placebo capsules will be administered orally or via a nasogastric feeding tube if the participant has dysphagia.
Study summary
The aim of this study is to assess the efficacy and safety of minocycline in improving functional outcome among patients with acute ischaemic stroke receiving intravenous thrombolysis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 80 years;
2. Patients with acute ischaemic stroke confirmed by CT or MRI;
3. 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);
4. The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
5. 6≤NIHSS≤25, and Ia≤1;
6. Signed informed consent.
Exclusion Criteria:
1. mRS score ≥ 2 prior to onset of the current stroke;
2. History of pseudomembranous colitis or antibiotic-associated colitis;
3. Known allergy or intolerance to tetracycline antibiotics or any component of minocycline;
4. Known resistance to other tetracyclines;
5. Use of tetracycline antibiotics within the past 7 days;
6. Presence of a known community-acquired bacterial infection (e.g., pneumonia, urinary tract infection) or any other concurrent infection requiring antibiotic treatment;
7. History of intracranial hemorrhagic disease within the past 3 months, for example, parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma.
8. 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;
9. Rare or unknown etiology of large vessel occlusion (e.g., arterial dissection, vasculitis);
10. History of systemic lupus erythematosus;
11. 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);
12. Use of tretinoin, androgen or antiandrogen treatment (e.g., anabolic steroids, spironolactone) within the past 3 months;
13. Pregnant, breastfeeding, or of childbearing potential who are unwilling to use effective contraception throughout the study;
14. Presence of a severe non-cardio-cerebrovascular disease with a life expectancy of less than 6 months;
15. Participation in any other clinical trial within the past 30 days;
16. 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.
Primary outcome measure(s)
Excellent functional outcome (mRS of 0-1) — 90 days Defined as an modified Rankin Scale (mRS) score of 0 or 1. The mRS scores range from 0 (no symptoms) to 5 (severe disability) and 6 (death).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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