Ischemic StrokeNCT04142151
Double Randomized and Placebo Controlled Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent Ischemic Stroke
A study testing Sanchitongshu, Aspirin and Clopidogrel in people with Ischemic Stroke and Antiplatelet Effect, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This clinical trail will evaluate the effect of Sanchitongshu combined with antiplatelet drugs (Aspirin or Clopidogrel) in the treatment of high-risk ischemic stroke patients in adults. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ischemic Stroke, Antiplatelet Effect
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2020
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20yrs to 85yrs;
- Anticipated patients within 8-90 days without cardiac ischemic stroke; Responsible lesions of all cases must be confirmed by a head MRI;
- have ability to take the drugs;
- No serious complications, liver and kidney function is normal;
- At least one of the following (a-c):
- Confirmed by MRA, CTA or DSA that stenosis of intracranial aorta beyond 50% (in A2, M2 or P2)
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- Confirmed by MRA, CTA or DSA that stenosis of cranial artery beyond 50% (carotid artery, intra-carotid artery, vertebral artery, head artery, or lower collarbone artery)
- ESRS score beyond 3
- Take Clopidogre or aspirin alone for antiplatelet treatment with informed consent
- Willing to participate in the clinical trial and willing to be followed up with, have signed informed consent
Who cannot join
- Younger than 20 yrs or elder than 85 yrs;
- The neurological function defects caused by brain hemorrhage or other conditions (e.g. vascular malformations, tumors, abscesses or other non-ischemic cerebrovascular diseases);
- Isolated sensory symptoms (e.g. numbness), isolated visual abnormalities, isolated dizziness and dizziness but have no responsibility lesions in head MRI;
- Stroke is caused by angiography or surgery operation;
- Stroke caused by cardio-induced embolism according to TOAST;
- Anticoagulant evidence (heart thrombosis, such as atrial fibrillation, heart valve replacement surgery operation)
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- Contraindications of MRI examination, such as claustrophobia or implanted pacemakers
- Severe heart and lung impairment; liver function laboratory indicator AST or ALT is 2x maximum normal value, or renal function laboratory indicator serum creatinine is 1.5X maximum normal value;
- Plan to accept vascular surgery during the trial period (e.g. epidermal angioplasty, stent placement and bypass transplants, etc.); Surgical or interventional treatment requires discontinuation of research drugs
- History of drug elution coronary stent implantation within one year
- Congestive heart failure or uncontrolled Angina pectoris;
- Platelet reduction (platelet count less than 10000/mm3);
- Symptomatic non-traumatic intracranial bleeding, any other bleeding disorder, bleeding tendency or clotting dysfunction;
- History of gastrointestinal ulcers, gastrointestinal bleeding, or surgical history within the last 3 months;
- Severe complications of non-cardiovascular and life expectancy less than 3 months;
- Have malignant tumors which in course of treatment;
- History of allergies to SanqiTongshu;
- Aspirin users have any of the following conditions: (1) History of allergy to aspirin or salicylic acid analogues (2) Pepsi ulcers (3) asthma or asthma history caused by aspirin;
- Allergy history of clopidogrel;
- History of alcohol or drugs abuse in the past 12 months;
- Pregnant, lactating women, or women who do not take effective contraception;
- There are other serious diseases or abnormal laboratory results who is not suitable to participate the study;
- Those who are participating in other clinical trials or clinical trials completed in past 3 months;
- Patients do not understand the study, or are unable to/unwilling to follow the provisions of the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhenguo Liu
Shanghai, Shanghai Municipality, 200092
Zhenguo Liu, 8602125077501 ext. 8602125077501, zhenguoliu2004@aliyun.com
Zhiyin Lou, 8602125077504 ext. 8602125077504, louzhiyin2003@163.com
About this study
Official title: The Randomized, Double-blind, Placebo-controlled Clinical Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent High-risk Ischemic Stroke Recurrence
This clinical trail will evaluate the effect of Sanchitongshu combined with antiplatelet drugs (Aspirin or Clopidogrel) in the treatment of high-risk ischemic stroke patients in adults. Half of participants will receive SanchiTongshu and one of antiplatelet drugs (Aspirin or Clopidogrel) in combination, while the other half will receive a placebo and one of antiplatelet drugs (Aspirin or Clopidogrel).
Read the detailed description
The aim of this clinical trail is to evaluate the effect of Sanchitongshu in the treatment of high-risk ischemic stroke patients in adults. All patients included in the study should meet the inclusion criteria. All participants will receive one of antiplatelet drugs (Aspirin or Clopidogrel). Half of participants will receive Sanchitongshu and Aspirin or Clopidogrel, while the other half will receive a placebo and Aspirin or Clopidogrel. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
- Conditions
- Ischemic Stroke, Antiplatelet Effect
- Being tested
- Sanchitongshu, Aspirin, Clopidogrel, placebo of Sanchitongshu
- Keywords
- Ischemic stroke, Sanchitongshu, Aspirin, Clopidogrel
- Medical subject headings
- Ischemic Stroke
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
SanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd.
AspirinDrug
Also called Bayaspirin Enteric-coated Tablets
Aspirin produced by Bayer Co., Ltd.
ClopidogrelDrug
Also called Clopidogrel Bisulfate
Clopidogrel produced by Shenzhen Salubris Co., Ltd.
placebo of SanchitongshuDrug
Also called Placebo
SanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| SanchiTongshu group | Active comparator | 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.
Drug: Aspirin or Clopidogrel Receives: Drug: Sanchitongshu; Drug: Aspirin; Drug: Clopidogrel |
| SanchiTongshu Placebo group | Placebo comparator | Drug: placebo of Sanchitongshu The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).
Drug: Aspirin or Clopidogrel Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: placebo of Sanchitongshu |
What is being measured
The primary outcome is the main question the study is designed to answer.
New stroke attack
Any type of stroke events attack or recurrence
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenguo Liu, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142151
- Sponsor's protocol ID
- XH-19-007
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized, Double-blind, Placebo-controlled Clinical Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent High-risk Ischemic Stroke Recurrence
- ClinicalTrials.gov ID
- NCT04142151
- Acronym / sponsor ID
- XH-19-007
- Conditions
- Ischemic Stroke, Antiplatelet Effect
- Keywords
- Ischemic stroke, Sanchitongshu, Aspirin, Clopidogrel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- 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.
This clinical trail will evaluate the effect of Sanchitongshu combined with antiplatelet drugs (Aspirin or Clopidogrel) in the treatment of high-risk ischemic stroke patients in adults. Half of participants will receive SanchiTongshu and one of antiplatelet drugs (Aspirin or Clopidogrel) in combination, while the other half will receive a placebo and one of antiplatelet drugs (Aspirin or Clopidogrel).
Detailed description
The aim of this clinical trail is to evaluate the effect of Sanchitongshu in the treatment of high-risk ischemic stroke patients in adults. All patients included in the study should meet the inclusion criteria. All participants will receive one of antiplatelet drugs (Aspirin or Clopidogrel). Half of participants will receive Sanchitongshu and Aspirin or Clopidogrel, while the other half will receive a placebo and Aspirin or Clopidogrel. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SanchiTongshu group | Active comparator | Drug: Sanchitongshu, Drug: Aspirin, Drug: ClopidogrelDrug: 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. Drug: Aspirin or Clopidogrel |
| SanchiTongshu Placebo group | Placebo comparator | Drug: Aspirin, Drug: Clopidogrel, Drug: placebo of SanchitongshuDrug: placebo of Sanchitongshu The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch). Drug: Aspirin or Clopidogrel |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age from 20yrs to 85yrs;
- Anticipated patients within 8-90 days without cardiac ischemic stroke; Responsible lesions of all cases must be confirmed by a head MRI;
- have ability to take the drugs;
- No serious complications, liver and kidney function is normal;
- At least one of the following (a-c):
Key exclusion criteria (24 listed)
- Younger than 20 yrs or elder than 85 yrs;
- The neurological function defects caused by brain hemorrhage or other conditions (e.g. vascular malformations, tumors, abscesses or other non-ischemic cerebrovascular diseases);
- Isolated sensory symptoms (e.g. numbness), isolated visual abnormalities, isolated dizziness and dizziness but have no responsibility lesions in head MRI;
- Stroke is caused by angiography or surgery operation;
- Stroke caused by cardio-induced embolism according to TOAST;
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 extractSanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd. | Drug | SanchiTongshu group |
| AspirinAlso: Bayaspirin Enteric-coated TabletsAspirin produced by Bayer Co., Ltd. | Drug | SanchiTongshu Placebo group, SanchiTongshu group |
| ClopidogrelAlso: Clopidogrel BisulfateClopidogrel produced by Shenzhen Salubris Co., Ltd. | Drug | SanchiTongshu Placebo group, SanchiTongshu group |
| placebo of SanchitongshuAlso: PlaceboSanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd. | Drug | SanchiTongshu Placebo group |
Primary outcome
New stroke attack
Time frame: 24 hours
Any type of stroke events attack or recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Zhenguo Liu principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sanchitongshu, Aspirin and Clopidogrel in people with Ischemic Stroke and Antiplatelet Effect, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 10 inclusion and 24 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zhiyin Lou, Doctor (86-021-25077504 ext. 8613611660696, louzhiyin2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New stroke attack (time frame: 24 hours). 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 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.