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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 : Unknown
Verified November 2016 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 29, 2016
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sanchitongtshu Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Study
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke, Acute
  • Ischemic Attack, Transient
Intervention  ICMJE
  • Drug: Sanchitongshu
    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
  • Drug: placebo of Sanchitongshu
    The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).
  • Drug: Aspirin
    Other Name: Aspirin Enteric-coated Tablets
  • Drug: Clopidogrel
    Other Name: Clopidogrel Bisulfate
  • Drug: placebo of clopidogrel
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Sanchitongshu
    • Drug: Aspirin
    • 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
    Interventions:
    • Drug: placebo of Sanchitongshu
    • Drug: Aspirin
    • Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age of 40 years to 80 years
  2. diagnosis of an acute minor ischemic stroke or transient ischemic attack; and ability to start the study drug within 24 hours after symptom onset, which was defined as the point at which the patient reported no longer being in a normal condition. Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale(NIHSS). TIA was defined as focal brain ischemia with resolution of symptoms within 24 hours after onset plus a moderate-to-high risk of stroke recurrence(defined as a score≥4 at the time of randomization on the ABCD2). All patients were confirmed by brain CT or MRI.
  3. Patients had ability to accept the medicine and rules of the research.
  4. Patients had no serious complications and had normal renal function and liver function.

Exclusion Criteria:

  1. age younger than 40 and older than 80
  2. Patients need thrombolysis
  3. hemorrhage; other conditions, such as vascular malformation, tumor, abcess, or other major nonischemic brain disease
  4. isolated sensory symptoms(e.g., numbness), isolated visual changes, or isolated dizziness or vertigo without evidence of acute infarction on baseline CT or MRI of the head
  5. a score of more than 2 on the modified Rankin scale(scores ranges from 0(no symptoms) to 6(death))immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
  6. TIA or minor stroke caused by angiography or surgery
  7. a clear indication for anticoagulation therapy(presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardio valve)
  8. anticipated requirement for long-term nonstudy antiplatelet drugs or for non steroidal antiinflammatory drugs affecting platelet function
  9. accompanied with severe disorders of heart, liver, and kidney
  10. severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months.
  11. history of hemorrhage or bleeding tendency of other system( such as thrombocytopenic purpura)
  12. gastrointestinal bleeding or major surgery within the previous 3 months
  13. planned or probable revascularization(any angioplasty or vascular surgery)within 3 months after.Operation or Interventional Therapy require discontinuation of study drug
  14. Aspirin, clopidogrel or notoginseng allergy
  15. a history of alcoholism or drug abuse in past 12 months
  16. pregnant and lactating women, or women of childbearing age without taking any effective contraceptive measures
  17. patients have other serious disease or abnormal laboratory results that is unfavorable to join the research
  18. patients receiving other investigational drugs or devices
  19. incomprehension of the character and category of the research and unable to follow the research plan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02975076
Other Study ID Numbers  ICMJE XH-16-037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xinhua Hospital Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP