Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy
- Conditions
- Ischemic Stroke, Acute
- Interventions
- Registration Number
- NCT05836753
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarecycline treatment group Sarecycline Tablet The first dose should be given immediately after randomization (within 30 minutes); Take one tablet once a day for 7 days continuously (the patient with dysphagia will be administrated through a nasal feeding tube). Sarecycline placebo control group Placebo tablets of Sarecycline tablets The control group received Sarecycline placebo tablets (each containing Sarecycline 0 mg) in the same way as the experimental group.
- Primary Outcome Measures
Name Time Method Changes of NIHSS score between baseline and at 7 days after randomization. at 7 days after randomization National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome）
- Secondary Outcome Measures
Name Time Method Early neurological deterioration at 72 hours after randomization. at 72 hours after randomization. Early neurological deterioration
Early neurological deterioration at 7 days after randomization. at 7 days after randomization Early neurological deterioration
Quality of life (EQ-5D) score at 90 days after randomization. at 90 days after randomization EuroQol Five Dimensions Questionnaire
Changes of NIHSS score between baseline and within 2 hours after reperfusion. 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）
Changes of NIHSS score between baseline and 72 hours after randomization. at 72 hours after randomization National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome）
Changes of infarction volume between baseline and at 72 hours after randomization. at 72 hours after randomization Infarction volume
Changes of cerebral blood perfusion between baseline and at 72 hours after randomization. at 72 hours after randomization Cerebral blood perfusion evaluated by CTP
The proportion of combined vascular events (recurrent stroke, myocardial infarction, and vasogenic death) at 90 days after randomization. at 90 days after randomization Combined vascular events (recurrent stroke, myocardial infarction, and vasogenic death)
Modified Rankin Scale (mRS) score at 90 days after randomization. at 90 days after randomization Modified Rankin Scale (mRS 0-5 scores; higher scores mean a worse outcome）
Changes of collateral circulation compensation between baseline and at 72 hours after randomization. at 72 hours after randomization Collateral circulation compensation
Trial Locations
- Locations (1)
Beijing Tiantan Hospital
🇨🇳Beijing, China