Sanchitongtshu Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Study
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|ClinicalTrials.gov Identifier: NCT02975076|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute Ischemic Attack, Transient||Drug: Sanchitongshu Drug: placebo of Sanchitongshu Drug: Aspirin Drug: Clopidogrel Drug: placebo of clopidogrel||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Radix/Rhizoma Notoginseng Extract (Sanchitongtshu) Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Placebo-controlled Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Sanchitongshu & placebo of lopidogrel
sanchitongshu 1 capsule each time ,three times a day and Aspirin 75mg for 90 days ; placebo of clopidogrel 75mg daily for 21 days after randomization
The study drugs were manufactured according to Good Manufacturing Practice (GMP) by the Pharmaceutical Factory of Chengdu Huasun Group Inc. Ltd. and presented in the form capsules. Every Sanchitongshu capsule weighed 200 mg, contained 100 mg of panaxatriol saponin (PTS) and 100 mg inactive excipient (starch). PTS comprised of dried extracts from roots of Radix Notoginseng, and had been standardised with respect to Ginsenoside Rg1 (50%), Ginsenoside Re (6%), Notoginsenoside R1 (11%). The amounts of the active ingredients were determined by analytical RP-HPLC using an acetonitrile-water gradient system as mobile hase. The peaks were detected by UV-DAD.
Other Name: Radix/Rhizoma Notoginseng extract
Other Name: Aspirin Enteric-coated Tablets
Drug: placebo of clopidogrel
Placebo Comparator: placebo of Sanchitongshu & lopidogrel
placebo of sanchitongshu1 capsule each time ,three times a day and Aspirin 75mg for 90 days;clopidogrel 75mg per day for 21 days after randomization
Drug: placebo of Sanchitongshu
The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).
Other Name: Aspirin Enteric-coated Tablets
Other Name: Clopidogrel Bisulfate
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975076
|Contact: Xiaorong Wang, Masterfirstname.lastname@example.org|
|Contact: Fei Luemail@example.com|
|Study Director:||Xinhua Hospital||Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine|