NCT05836753

Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy

Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy: A Phase II, Randomized, Multicenter, Double-blind, Single Dose, Placebo-controlled Parallel Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
DRUG	Sarecycline Tablet	Each tablet contained 100 mg of Sarecycline.
DRUG	Placebo tablets of Sarecycline tablets	Each tablet contained 0 mg of Sarecycline.

Timeline

• Start date: 2023-05-07
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2023-05-01
• Last updated: 2023-07-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study