Stroke, AcuteNCT02975076
Sanchitongtshu Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Study
A study testing Sanchitongshu, Aspirin and Clopidogrel in people with Stroke, Acute and Ischemic Attack, Transient, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Acute, Ischemic Attack, Transient
- What is being tested?
- Sanchitongshu, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 40 years to 80 years
- 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.
- Patients had ability to accept the medicine and rules of the research.
- Patients had no serious complications and had normal renal function and liver function.
Who cannot join
- age younger than 40 and older than 80
- Patients need thrombolysis
- hemorrhage; other conditions, such as vascular malformation, tumor, abcess, or other major nonischemic brain disease
- 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
- 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
- TIA or minor stroke caused by angiography or surgery
Show all 19Show fewer
- a clear indication for anticoagulation therapy(presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardio valve)
- anticipated requirement for long-term nonstudy antiplatelet drugs or for non steroidal antiinflammatory drugs affecting platelet function
- accompanied with severe disorders of heart, liver, and kidney
- severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months.
- history of hemorrhage or bleeding tendency of other system( such as thrombocytopenic purpura)
- gastrointestinal bleeding or major surgery within the previous 3 months
- planned or probable revascularization(any angioplasty or vascular surgery)within 3 months after.Operation or Interventional Therapy require discontinuation of study drug
- Aspirin, clopidogrel or notoginseng allergy
- a history of alcoholism or drug abuse in past 12 months
- pregnant and lactating women, or women of childbearing age without taking any effective contraceptive measures
- patients have other serious disease or abnormal laboratory results that is unfavorable to join the research
- patients receiving other investigational drugs or devices
- incomprehension of the character and category of the research and unable to follow the research plan
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radix/Rhizoma Notoginseng Extract (Sanchitongtshu) Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Placebo-controlled Study
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.
Read the 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.
- Conditions
- Stroke, Acute, Ischemic Attack, Transient
- Being tested
- Sanchitongshu, placebo of Sanchitongshu, Aspirin, Clopidogrel, placebo of clopidogrel
- Keywords
- Sanchitongshu, Acute Minor Stroke, Transient Ischemic Attack
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SanchitongshuDrug
Also called Radix/Rhizoma Notoginseng extract
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.
placebo of SanchitongshuDrug
The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).
AspirinDrug
Also called Aspirin Enteric-coated Tablets
ClopidogrelDrug
Also called Clopidogrel Bisulfate
placebo of clopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Sanchitongshu & placebo of lopidogrel | Experimental | 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 Receives: Drug: Sanchitongshu; Drug: Aspirin; Drug: placebo of clopidogrel |
| placebo of Sanchitongshu & lopidogrel | Placebo comparator | 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 Receives: Drug: placebo of Sanchitongshu; Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with the180-day new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
Measured: 180 days
Secondary outcomes (10)
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
Measured: 180 days
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 180 days follow-up
Measured: 180 days
Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 180 days follow-up)
Measured: 180 days
Further efficacy exploratory analysis:Impairment (changes in Barthel Index at 180 days follow-up)
Measured: 180 days
Further efficacy exploratory analysis: stroke impact scale
Measured: 180 days
Efficacy endpoint will also be analyzed stratified by etiological subtypes
Measured: 180 days
death from any cause
Measured: 180 days
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
Measured: 180 days
Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 180 days
Measured: 180 days
Incidence Intracranial hemorrhage events at 180 days
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinhua Hospital, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975076
- Sponsor's protocol ID
- XH-16-037
- Status last verified
- Nov 2016
- First submitted
- 18 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radix/Rhizoma Notoginseng Extract (Sanchitongtshu) Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02975076
- Acronym / sponsor ID
- XH-16-037
- Conditions
- Stroke, Acute, Ischemic Attack, Transient
- Keywords
- Sanchitongshu, Acute Minor Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanchitongshu & placebo of lopidogrel | Experimental | Drug: Sanchitongshu, Drug: Aspirin, Drug: placebo of clopidogrelsanchitongshu 1 capsule each time ,three times a day and Aspirin 75mg for 90 days ; placebo of clopidogrel 75mg daily for 21 days after randomization |
| placebo of Sanchitongshu & lopidogrel | Placebo comparator | Drug: placebo of Sanchitongshu, Drug: Aspirin, Drug: Clopidogrelplacebo of sanchitongshu1 capsule each time ,three times a day and Aspirin 75mg for 90 days;clopidogrel 75mg per day for 21 days after randomization |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age of 40 years to 80 years
- 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.
- Patients had ability to accept the medicine and rules of the research.
- Patients had no serious complications and had normal renal function and liver function.
Key exclusion criteria (19 listed)
- age younger than 40 and older than 80
- Patients need thrombolysis
- hemorrhage; other conditions, such as vascular malformation, tumor, abcess, or other major nonischemic brain disease
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SanchitongshuAlso: Radix/Rhizoma Notoginseng extractThe 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. | Drug | Sanchitongshu & placebo of lopidogrel |
| placebo of SanchitongshuThe Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch). | Drug | placebo of Sanchitongshu & lopidogrel |
| AspirinAlso: Aspirin Enteric-coated Tablets | Drug | Sanchitongshu & placebo of lopidogrel, placebo of Sanchitongshu & lopidogrel |
| ClopidogrelAlso: Clopidogrel Bisulfate | Drug | placebo of Sanchitongshu & lopidogrel |
| placebo of clopidogrel | Drug | Sanchitongshu & placebo of lopidogrel |
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinhua Hospital study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Sanchitongshu, Aspirin and Clopidogrel in people with Stroke, Acute and Ischemic Attack, Transient, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong Wang, Master (13621712767, wangxr_mail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.