A Phase 3 interventional study of Minocycline Hydrochloride Capsule (50 mg per capsule) and Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline) in Ischaemic Stroke, sponsored by Beijing Tiantan Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Treatment
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.
Minocycline, a broad-spectrum tetracycline antibiotic, has been shown to possess a wide range of cytoprotective properties independent of its antibacterial activity, which have translated into promising therapeutic potential for acute ischaemic stroke. Specifically, the drug improves post-stroke outcomes by targeting post-ischaemic neuroinflammation through multiple mechanisms. Early-phase clinical trials first indicated that minocycline treatment, initiated within 6-24 hours after stroke, could improve functional outcomes for up to 90 days. This promise was recently substantiated by the EMPHASIS trial, which demonstrated that minocycline administered within 72 hours of ischaemic stroke onset significantly improved 90-day functional outcomes compared to placebo, with a favorable safety profile. Furthermore, preclinical research has shown that combining minocycline with t-PA can improve thrombolytic efficacy, extend the therapeutic time window, and reduce the risk of hemorrhagic transformation. Hence, this study-a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial-aims to evaluate whether minocycline improves functional outcomes in patients with acute ischaemic stroke undergoing intravenous thrombolysis.
Patients aged 18 to 80 years with a newly diagnosed ischaemic stroke (NIHSS score of 6-25 and Ia ≤1), who have received/are planned to receive intravenous thrombolysis within 4.5 hours of onset or within an extended window of 4.5-24 hours based on guideline recommendations, and can be treated with the study drug either before thrombolysis or within 2 hours after its initiation, will be enrolled. Eligible patients will be randomly assigned in a 1:1 ratio to receive minocycline or placebo.
The primary efficacy outcome is an excellent functional outcome (a mRS score of 0 or 1) at 90 days. The secondary efficacy outcomes include a good functional outcome (a mRS score of 0 to 2) at 90 days, the ordinal distribution of mRS score at 90 days, quality of life (EQ-5D) score at 90 days, a Barthel Index score of at least 95 at 90 days, the change from baseline in the NIHSS score at 6 days, and major neurologic improvement at 6 days (defined as a decrease from baseline of ≥ 4 points on the NIHSS, or an NIHSS score of ≤1). Safety outcomes include diarrhoea, enteritis, and constipation within 6 days, symptomatic intracranial hemorrhage within 6 days, any bleeding events, adverse events or serious adverse events within 90 days.
Randomized participants will be interviewed at screening/baseline period, 6 days, 30±3 days, 60±5 days, and 90±7 days after randomization.
Exclusion Criteria:
This group will receive minocycline hydrochloride capsules.
Drug: Minocycline Hydrochloride Capsule (50 mg per capsule)
This group will receive placebo of minocycline hydrochloride capsules.
Drug: 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. Minocycline hydrochloride capsules will be administered orally or via a nasogastric feeding tube if the participant has dysphagia.
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.
Excellent functional outcome (mRS of 0-1)
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).
Time frame: 90 days
Good functional outcome (mRS of 0-2)
Defined as an modified Rankin Scale (mRS) score of 0 or 2. The mRS scores range from 0 (no symptoms) to 5 (severe disability) and 6 (death).
Time frame: 90 days
Distribution of mRS score
The ordinal distribution of mRS score of 0 to 6 points
Time frame: 90 days
Quality of life score (EQ-5D scale)
The European Quality of Life 5-Dimension (EQ-5D）questionnaire for measuring generic health status. The 5-level EQ-5D version (EQ-5D-5L) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 25 (all domains have level 5), with higher scores indicating worse health-related quality of life.
Time frame: 90 days
Barthel Index score ≥ 95
The Barthel index score ranges from 0 to 100, with higher scores indicating better independent function.
Time frame: 90 days
Changes from baseline of National Institutes of Health Stroke Scale (NIHSS) score
Defined as the difference between the 6-day NIHSS score and the baseline NIHSS score. The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: 6 days
Major neurologic improvement
Defined as NIHSS score ≤ 1 point at 6 days or an improvement of ≥ 4 points compared to the baseline NIHSS score. The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: 6 days
The proportion of participants with diarrhoea, enteritis, and constipation
Time frame: 6 days
The proportion of participants with symptomatic intracranial hemorrhage
Defined by the European Cooperative Acute Stroke Study III (ECASS III)
Time frame: 6 days
The proportion of participants with any bleeding events
Defined by the Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries Criteria (GUSTO)
Time frame: 90 days
The proportion of participants with adverse events
Time frame: 90 days
The proportion of participants with serious adverse events
Time frame: 90 days
Plan to share: No
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Beijing Tiantan Hospital