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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 no
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: Percentage of patients with the180-day new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) [ Time Frame: 180 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of patients with the 180-day new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually [ Time Frame: 180 days ]
  • Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 180 days follow-up [ Time Frame: 180 days ]
  • Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 180 days follow-up) [ Time Frame: 180 days ]
  • Further efficacy exploratory analysis:Impairment (changes in Barthel Index at 180 days follow-up) [ Time Frame: 180 days ]
  • Further efficacy exploratory analysis: stroke impact scale [ Time Frame: 180 days ]
  • Efficacy endpoint will also be analyzed stratified by etiological subtypes [ Time Frame: 180 days ]
  • death from any cause [ Time Frame: 180 days ]
  • Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. [ Time Frame: 180 days ]
  • Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 180 days [ Time Frame: 180 days ]
  • Incidence Intracranial hemorrhage events at 180 days [ Time Frame: 180 days ]


Original Secondary Outcome: Same as current

Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: November 18, 2016
Date Started: December 2016
Date Completion: November 2019
Last Updated: November 22, 2016
Last Verified: November 2016