Sanchitongtshu Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Study

Stroke, Acute Clinical Trial

Official title: Radix/Rhizoma Notoginseng Extract (Sanchitongtshu) Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Placebo-controlled Study

Status Not yet recruiting

Clinical Trial Summary

Agents of sanchi have been widely used as a complementary medicine for stroke in China. Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger anti-platelet activity than other agents of sanchi. The investigators's aim was to investigate the synergistic action of aspirin combined with sanchitongshu capsule in the treatment of patients with minor ischemic stroke and transient ischemic attack.

Clinical Trial Description

Transient ischemic attack (TIA) and acute minor ischemic stroke are common and often lead to disabling events. In China, there are approximately 3 million new strokes every year, and approximately 30% of them are minor ischemic strokes. The incidence of TIA in China has not been determined, but on the basis of the incidence in other countries, there are probably more than 2 million TIAs annually in China. The risk of another stroke occurring after a TIA or minor stroke is high, with approximately 10 to 20% of patients having a stroke within 3 months after the index event; most of these strokes occur within the first 2 days. The role of antiplatelet therapy for secondary stroke prevention has been well established.

As yet, aspirin is the only antiplatelet agent that has been studied in the acute phase of stroke, during which its benefit is modest. Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial shows that among patients with high-risk TIA or minor ischemic stroke who are initially seen within 24 hours after symptom onset, treatment with clopidogrel plus aspirin for 21 days, followed by clopidogrel alone for a total of 90 days, is superior to aspirin alone in reducing the risk of subsequent stroke events. The combination of clopidogrel with aspirin did not cause more hemorrhagic events in this patient population than aspirin alone. The analytical results provided basis for the synergistical effect of Aspirin and clopidogrel in inhibiting platelet aggregation. However, long term use of clopidogrel bring people financial burden so that the patients have less compliance of medication. Therefore, the investigators need to explore new treatment for more effective, safe and economic.

Sanchi is one of the most widely used herbal medicine in China for ischemic stroke, of which panax notoginseng saponins (PNS) are the main active components. Previously there were lots of clinical trials on agents of PNS for ischemic stroke in China and had positive results. Sanchitongshu capsule is a new Chinese patent medicine extracted from sanchi. 80% of the ingredients in sanchi-tongshu capsule are panaxatriol saponins (PTS) and 60% of PTS are Rg1 which has strongest anti-platelet activity of all the PNS. PTS were proven by experiment and phase III clinical trials to have antithrombosis effect through mechanisms of inhibiting platelet aggregation, decreasing blood viscosity, strengthening activities of fibrinolysis system, and promoting vascular endothelial NO releasing. More recent experimental studies indicated anti-inflammatory and neuroprotective effect of PTS. Compared with other agents of Sanchi, Sanchitongshu capsule contains higher purity of PTS and Rg1. Thus, Sanchitongshu capsule theoretically should be vigorous in improving ischemic status after ischemic stroke.

Include, the investigators will investigate the synergistic action of aspirin combined with sanchitongshu capsule in the treatment of patients with minor ischemic stroke and transient ischemic attack. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Stroke, Acute

• NCT number: NCT02975076
• Study type: Interventional
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xiaorong Wang, Master
• Phone: 13621712767
• Email: wangxr_mail@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2016
• Completion date: November 2019