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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,724
50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
50 mg per capsule, containing 0mg of Minocycline Hydrochloride.
mRS score 0-1
Modified Rankin Scale score.
Time frame: At 90±7 days after randomization.
mRS score.
Modified Rankin Scale score.
Time frame: At 90±7 days after randomization.
Changes in NIHSS score compared with baseline score.
NIHSS score
Time frame: At 24±1 hours and 6±1 days after randomization.
Changes in hs-CRP level compared with baseline level.
hs-CRP was examined to evaluate the level of systematic inflammation
Time frame: At 6±1 days after randomization.
Early neurological deterioration.
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.
Time frame: At 24±2 hours and 6±1 days after randomization.
Recurrent stroke.
Recurrent stroke includes recurrent ischemic stroke and recurrent hemorrhagic stroke.
Time frame: At 90±7 days after randomization.
Recurrent ischemic stroke.
The condition of recurrent ischemic stroke.
Time frame: At 90±7 days after randomization.
Combined vascular events.
Combined vascular events referred to stroke, myocardial infarction, and vascular death.
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The Eighth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Shunyi Hospital
Beijing, Beijing Municipality, China
Chongqing Donghua Hospital
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 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
...and 48 more locations
Time frame: At 90±7 days after randomization.
Quality of life (EQ-5D) score.
Scores of EuroQol (Quality of life) -5 Dimensions.
Time frame: At 90±7 days after randomization.