Background: Although revascularization treatment is recommended as the first-line
therapy for patients with non-minor
acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of Panax notoginseng
saponins (PNS) (
Xueshuantong lyophilized
powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS
therapy for patients with AIS. Methods: The Evaluation of
Xueshuantong in Patients with
acutE ischemiC sTroke (EXPECT) trial is a multicenter, randomized, placebo-controlled, double-blind study aiming to enroll 480 patients in China. Eligible patients with AIS within 72 h of symptom onset will randomly receive either PNS or PNS placebo for 10 days and subsequently be followed up to 90 days. The primary outcome will be a change in the National Institute of Health
Stroke Scale (NIHSS) score from baseline to 10 post-randomization days. The secondary outcomes include early neurological improvement (proportion of patients with NIHSS score 0-1), and Patient-Reported Outcomes Scale for
Stroke score
at 10 post-randomization days, the proportion of patients with life independence (modified Rankin Scale score of 0-1), the proportion of patients with a favorable outcome (Barthel Index ≥90), and
Stroke-Specific Quality of Life score at 90 days. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of PNS. Conclusions: To our knowledge, this study is the first double-blind trial to assess the efficacy and safety of PNS in patients with AIS. Findings of the EXPECT trial will be valuable in improving evidence regarding the clinical application of PNS
therapy in patients with AIS ineligible for revascularization treatment in the reperfusion era.