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NCT07526987
Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis
Conditions: Ischaemic Stroke
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 934
Sponsor: Beijing Tiantan Hospital
Location: Liaocheng Third People's Hospital Liaocheng Shandong
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07526987). StuddyBuddy aggregates publicly available trial information.