The aim of this study was to evaluate the efficacy and safety of Sarecycline versus placebo in the treatment of microcirculation dysfunction after reperfusion therapy in patients with large vessel occlusion stroke.
This study evaluated the efficacy and safety of 7-day Sarecycline versus placebo in patients with large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset. In addition, we will explore the effect of Sarecycline versus placebo on indicators of venous thrombotic inflammation at different time points in patients with acute ischemic stroke with large vessel occlusion. This trial was a prospective, randomized, multicenter, double-blind, placebo-controlled parallel trial. Patients with acute large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset were randomly assigned according to the ratio of the experimental group: control group =2:1. The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The primary research objective is to evaluate the effect of Sarecycline in improving neurological deficits at 7 days in patients with acute large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Each tablet contained 100 mg of Sarecycline.
Each tablet contained 0 mg of Sarecycline.
Beijing Tiantan Hospital
Beijing, China
RECRUITINGChanges of NIHSS score between baseline and at 7 days after randomization.
National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome)
Time frame: at 7 days after randomization
Changes of NIHSS score between baseline and within 2 hours after reperfusion.
National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome)al Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome) National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome)
Time frame: within 2 hours after reperfusion
Changes of NIHSS score between baseline and 72 hours after randomization.
National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome)
Time frame: at 72 hours after randomization
Early neurological deterioration at 72 hours after randomization.
Early neurological deterioration
Time frame: at 72 hours after randomization.
Early neurological deterioration at 7 days after randomization.
Early neurological deterioration
Time frame: at 7 days after randomization
Changes of infarction volume between baseline and at 72 hours after randomization.
Infarction volume
Time frame: at 72 hours after randomization
Changes of cerebral blood perfusion between baseline and at 72 hours after randomization.
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Cerebral blood perfusion evaluated by CTP
Time frame: at 72 hours after randomization
Changes of collateral circulation compensation between baseline and at 72 hours after randomization.
Collateral circulation compensation
Time frame: at 72 hours after randomization
Modified Rankin Scale (mRS) score at 90 days after randomization.
Modified Rankin Scale (mRS 0-5 scores; higher scores mean a worse outcome)
Time frame: at 90 days after randomization
Quality of life (EQ-5D) score at 90 days after randomization.
EuroQol Five Dimensions Questionnaire
Time frame: at 90 days after randomization
The proportion of combined vascular events (recurrent stroke, myocardial infarction, and vasogenic death) at 90 days after randomization.
Combined vascular events (recurrent stroke, myocardial infarction, and vasogenic death)
Time frame: at 90 days after randomization