This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.
The aim of this study was to evaluate the efficacy and safety of 5-day Minocycline versus placebo in patients with acute intracerebral hemorrhage within 48 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation at different time points in patients with acute intracerebral hemorrhage within 48 hours of onset. A total of 1192 participants will be randomized 1:1 to receive either minocycline or matching placebo for 5 days, in addition to guideline-based standard medical care. The primary objective is to evaluate the effect of Minocycline in improving the level of 90-day mRS score to 0-3 in patients with acute intracerebral hemorrhage within 48 hours of onset. The trial is divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants are interviewed at screening/baseline period, 72±12 hours, 7±1 days, 90±7 days,180±7 days after randomization, and when events occur.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,192
50 mg per capsule, containing 50mg of Minocycline Hydrochloride
50 mg per capsule, containing 0 mg of Minocycline Hydrochloride
mRS score 0-3
Modified Rankin Scale score
Time frame: At 90±7 days after randomization
mRS score
Modified Rankin Scale score
Time frame: At 90±7 days and 180±7 days after randomization
Changes in NIHSS score compared with baseline score
NIHSS score
Time frame: At 72±12 hours and 7±1 days after randomization
Changes in Glasgow Coma Scale score compared with baseline score
Glasgow Coma Scale score
Time frame: At 72±12 hours and 7±1 days after randomization
Early neurological deterioration
Early neurological deterioration is defined as a decrease of ≥2 in GCS score or an increase of ≥4 in NIHSS score caused by non-sedatives/sleeping drugs compared with the baseline level.
Time frame: At 72±12 hours and 7±1 days after randomization
Changes in hs-CRP level compared with baseline level
hs-CRP is examined to evaluate the level of systematic inflammation.
Time frame: At 72±12 hours and 7±1 days after randomization
Volume of perihematomal edema (PHE)
Volume of perihematomal edema (PHE) on MRI
Time frame: At 7±1 days after randomization
EQ-5D-5L utility score
Quality of life assessed by the EQ-5D-5L utility score
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing Tongnan District People's Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe Second People's Hospital of Guangdong Province
Guangzhou, Guangdong, China
RECRUITINGBaoding Fourth Central Hospital (Tangxian, Hebei)
Baoding, Hebei, China
RECRUITINGZhangjiakou First Hospital
Zhangjiakou, Hebei, China
NOT_YET_RECRUITINGZunhua People's Hospital
Zunhua, Hebei, China
RECRUITINGMengzhou Fuxing Hospital
Mengzhou, Henan, China
RECRUITINGNanle County People's Hospital
Nanle, Henan, China
RECRUITINGNeixiang County People's Hospital
Neixiang, Henan, China
RECRUITINGGeneral Hospital of Pingmei Shenma Medical Group
Pingdingshan, Henan, China
RECRUITING...and 31 more locations
Time frame: At 90±7 days and 180±7 days after randomization
Recurrent stroke
Recurrent stroke includes ischemic stroke and hemorrhagic stroke.
Time frame: At 90±7 days and 180±7 days after randomization
Combined vascular events
Combined vascular events include stroke, myocardial infarction, and vascular death.
Time frame: At 90±7 days and 180±7 days after randomization