Minocycline added to standard IV thrombolysis in acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study evaluates the safety and effectiveness of minocycline in adults with acute ischemic stroke who are receiving intravenous thrombolysis. Participants are randomized to receive minocycline capsules or matching placebo, started before thrombolysis or within 2 hours after starting, and followed for functional outcomes up to 90 days. The trial builds on prior data suggesting anti-inflammatory and neuroprotective effects of minocycline in stroke and aims to determine if adding it to standard thrombolysis improves disability-free survival. Key outcomes include functional status at 90 days and safety measures related to treatment. The study is conducted at several centers in China, led by Beijing Tiantan Hospital with regional participating sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Liaocheng Third People's Hospital
  Liaocheng, Shandong, China Recruiting
• Guanxian People's Hospital
  Liaocheng, Shandong, China Recruiting
• Beijing Tiantan Hospital
  Beijing, China Not yet recruiting

Study contacts

• Principal investigator: Yilong Wang, MD, PhD — Beijing Tiantan Hospital
• Study coordinator: Anxin Wang, PhD
• Email: wanganxin@bjttyy.com
• Phone: 8601059976951

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.