Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke
- Conditions
- Ischemic Stroke, Acute
- Interventions
- Drug: Placebo capsules of Minocycline hydrochloride capsules
- Registration Number
- NCT05836740
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.
- Detailed Description
The aim of this study was to evaluate the efficacy and safety of 4.5-days Minocycline versus placebo in patients with moderate to severe acute ischemic stroke within 72 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation and thrombo-inflammation at different time points in patients with moderate to severe acute ischemic stroke within 72 hours of onset.
The primary objective is to evaluate the effect of Minocycline in improving the level of mRS score to 0-1 in patients with moderate to severe acute ischemic stroke within 72 hours of onset.
The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants were interviewed at screening/baseline period, 24±2 hours, 6±1 days, 90±7 days after randomization, and when events occurred.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1724
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minocycline placebo-control group Placebo capsules of Minocycline hydrochloride capsules Placebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline) The method of administration was the same as that of treatment group. Minocycline treatment group Minocycline hydrochloride capsule Minocycline Hydrochloride Capsules (50 mg per capsule) The first dose should be given immediately after randomization (within 30 minutes); 200mg (4 capsules) for the first dose; Subsequently, 100mg (2 capsules) will be administered once every 12 hours, a total of 9 times (lasting 4.5 days; the subject with dysphagia will be administrated through a nasal feeding tube)
- Primary Outcome Measures
Name Time Method mRS score 0-1 At 90±7 days after randomization. Modified Rankin Scale score.
- Secondary Outcome Measures
Name Time Method Changes in NIHSS score compared with baseline score. At 24±1 hours and 6±1 days after randomization. NIHSS score
Changes in hs-CRP level compared with baseline level. At 6±1 days after randomization. hs-CRP was examined to evaluate the level of systematic inflammation
Quality of life (EQ-5D) score. At 90±7 days after randomization. Scores of EuroQol (Quality of life) -5 Dimensions.
mRS score. At 90±7 days after randomization. Modified Rankin Scale score.
Early neurological deterioration. At 24±2 hours and 6±1 days after randomization. Early neurological deterioration was defined as any new neurological symptoms or signs that occur within several hours or days of onset, as well as the progression of existing neurological deficit symptoms or signs.
Recurrent stroke. At 90±7 days after randomization. Recurrent stroke includes recurrent ischemic stroke and recurrent hemorrhagic stroke.
Recurrent ischemic stroke. At 90±7 days after randomization. The condition of recurrent ischemic stroke.
Combined vascular events. At 90±7 days after randomization. Combined vascular events referred to stroke, myocardial infarction, and vascular death.
Trial Locations
- Locations (58)
The Eighth Medical Center of PLA General Hospital
🇨🇳Beijing, Beijing, China
Beijing Shunyi Hospital
🇨🇳Beijing, Beijing, China
Chongqing Donghua Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
Shenzhen Hospital, Southern Medical University
🇨🇳Shenzhen, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Second Nanning People's Hospital
🇨🇳Nanning, Guangxi, China
The Sixth People's Hospital of Hengshui
🇨🇳Hengshui, Hebei, China
North China University of Science and Technology Affiliated Hospital
🇨🇳Tangshan, Hebei, China
Dengzhou People's Hospital
🇨🇳Dengzhou, Henan, China
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