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.
Age between 18 and 80 years;
Patients with acute ischaemic stroke confirmed by CT or MRI;
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);
The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
mRS score ≥ 2 prior to onset of the current stroke;
History of pseudomembranous colitis or antibiotic-associated colitis;
Known allergy or intolerance to tetracycline antibiotics or any component of minocycline;
Known resistance to other tetracyclines;
Parallel
Minocycline Hydrochloride Capsule (50 mg per capsule)
DrugA 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.
Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline)
DrugA 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).
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).
Distribution of mRS score
The ordinal distribution of mRS score of 0 to 6 points
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.
Barthel Index score ≥ 95
The Barthel index score ranges from 0 to 100, with higher scores indicating better independent function.
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