Endovascular thrombectomy (EVT) improves outcomes in patients with acute large vessel occlusion (LVO). However, despite successful recanalization rates exceeding 80%, fewer than 50% of patients achieve favorable functional outcomes at 90 days, indicating a high rate of futile recanalization. Potential mechanisms include no-reflow, reperfusion injury, and microcirculatory dysfunction, which are closely associated with post-recanalization neuroinflammation.
Minocycline is a second-generation tetracycline with pleiotropic neuroprotective effects, including inhibition of microglial activation, reduction of inflammatory mediators, suppression of matrix metalloproteinases, attenuation of oxidative stress, and preservation of blood-brain barrier integrity. Prior preclinical and clinical studies suggest that minocycline may improve neurological outcomes in acute ischemic stroke.
This study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate the safety and efficacy of adjunctive minocycline in patients with acute anterior circulation LVO who achieve successful recanalization after EVT. The trial will assess whether early administration of minocycline improves functional outcomes and reduces futile recanalization.
Age ≥18 years;
Pre-stroke mRS score of 0-1;
Time from symptom onset to randomization ≤24 hours, including wake-up stroke or unwitnessed stroke. Symptom onset is defined as the last known well time;
Baseline NIHSS score of 6-25;
Acute intracranial hemorrhage on CT or MRI;
Bilateral acute stroke or multiple intracranial large vessel occlusions;
Isolated extracranial internal carotid artery occlusion;
History of pseudomembranous colitis or antibiotic-associated colitis;
Parallel
Minocycline hydrochloride capsule
Drug50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
Placebo capsules of Minocycline hydrochloride capsules
Drug50 mg per capsule, containing 0mg of Minocycline Hydrochloride.
Excellent outcome
Rate of modified Rankin scale (mRS) 0-1 at 90±7 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).
Ordinal distribution of mRS
The shift analysis of mRS at 90±7 days
Functional independence
Rate of mRS 0-2 at 90±7 days
Ambulatory or bodily needs-capable or better
Rate of mRS 0-3 at 90±7 days
Quality of life (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score at 90±7 days The EQ-5D-5L is a standardized, preference-based measure of health-related quality of life covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five severity levels. The EQ-5D-5L index score typically ranges from less than 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better quality of life.
Symptomatic intracranial hemorrhage (sICH)
Rate of sICH after randomization (Heidelberg Bleeding Classification)
All-caused mortality
All cause mortality at 90±7 days
Any intracranial hemorrhage
Rate of any intracranial hemorrhage after randomization (Heidelberg Bleeding Classification)
Adverse events and serious adverse events
Incidences of adverse events and serious adverse events
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Xiang Luo
Lead sponsor
Tongji Hospital
Sponsor institution
