Abstract TMP1: Xuesaitong Improves The Prognosis Of Patients With Ischemic Stroke

Abstract

Introduction: Stroke, characterized by high morbidity, disability, and mortality, has become one of the major threats to human health. In recent years, many studies have begun to focus on the treatment of ischemic stroke by traditional Chinese medicine. Xuesaitong, extracted from the precious Chinese herbal medicine panax notoginseng, has shown strong neuroprotective effects in the laboratory. We conducted the present study to investigate the efficacy and safety of xuesaitong in patients with ischemic stroke. Hypothesis: For patients with ischemic stroke within 14 days of onset, the combination of xuesaitong soft capsule and aspirin can further improve the 90-day functional outcome. Methods: This multicenter, randomized, double-blind, placebo-controlled clinical trial including 3072 patients with ischemic stroke was conducted at 67 centers in China between July 30, 2018, and June 1, 2020. Eligible patients were randomly assigned to receive xuesaitong plus aspirin (xuesaitong group) or placebo plus aspirin (control group). The primary efficacy outcome was functional independence at 90 days, defined as a modified Rankin Scale score of 0 to 2. The primary safety outcome was serious adverse events at 90 days. Results: Among 3072 patients who were randomized, 2966 (96.5%) were included in the full analysis set to assess the efficacy outcome, 2970 (96.7%) were included in the safety set to assess the safety outcome. At 90 days, 1328/1487 (89.3%) patients in the xuesaitong group and 1218/1479 (82.4%) patients in the control group achieved functional independence (odds ratio, 1.79 [95% CI, 1.45-2.21]; P<0.001). The rate of serious adverse events was 15/1488 (1.01%) in the xuesaitong group versus 16/1482 (1.08%) in the control group (P=0.85). Conclusions: Among patients with ischemic stroke, xuesaitong plus aspirin significantly increased the likelihood of functional independence at 90 days. Trial registration: Chictr.org Identifier: ChiCTR1800016363.