Acute ischemic stroke (AIS) is a leading cause of mortality and long-term disability worldwide. Among these, stroke caused by large vessel occlusion (LVO) are associated with particularly poor outcomes. Multiple randomized controlled trials have demonstrated that endovascular thrombectomy (EVT) significantly improves clinical outcomes in patients with acute LVO and is recommended as the standard of care by current guidelines. Posterior circulation strokes account for approximately 20% of all ischemic strokes and are generally associated with worse prognosis than anterior circulation strokes, especially in patients with basilar artery occlusion, who have a markedly increased risk of death or severe disability. Despite EVT treatment, more than three-quarters of these patients remain dead or functionally dependent at 90 days, indicating substantial room for improvement.
Successful recanalization and restoration of effective cerebral perfusion are critical for achieving favorable outcomes. However, although recanalization rates exceed 80% with current thrombectomy techniques, fewer than 40 of patients achieve good functional outcomes at 90 days, suggesting a high incidence of futile recanalization. The underlying mechanisms may include no-reflow, reperfusion injury, and microcirculatory dysfunction, all of which are closely associated with post-recanalization neuroinflammation.
Minocycline is a second-generation tetracycline with pleiotropic neuroprotective properties, including inhibition of microglial activation, reduction of inflammatory mediators, suppression of matrix metalloproteinases, attenuation of oxidative stress, and preservation of blood-brain barrier integrity. Preclinical and clinical studies suggest that minocycline may improve neurological outcomes in patients with AIS.
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 posterior circulation arterial occlusion who achieve successful recanalization after EVT. The trial will assess whether early administration of minocycline improves functional outcomes and reduces the incidence of 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 ≥6;;
Acute intracranial hemorrhage on CT or MRI;
Occlusion involving both anterior and posterior circulations on CTA, MRA, or DSA (except in patients with a prior history of anterior circulation occlusion);
Complete bilateral thalamic infarction or bilateral brainstem infarction on CT or MRI;
Cerebellar infarction with significant mass effect or compression of the fourth ventricle on CT or MRI;
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.
Functional independence
Rate of mRS 0-2 at 90±7 days Defined as an modified Rankin Scale (mRS) score of 0 to 2. 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
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).
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
