ClinicalTrials.gg
Status unknownNCT04142151Updated Oct 29, 2019

Double Randomized and Placebo Controlled Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent Ischemic Stroke

An interventional study of Sanchitongshu and Aspirin in Ischemic Stroke and Antiplatelet Effect, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ischemic Stroke
  • Antiplatelet Effect

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Keywords

  • Ischemic stroke, Sanchitongshu, Aspirin, Clopidogrel
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age from 20yrs to 85yrs;
  2. Anticipated patients within 8-90 days without cardiac ischemic stroke; Responsible lesions of all cases must be confirmed by a head MRI;
  3. have ability to take the drugs;
  4. No serious complications, liver and kidney function is normal;
  5. At least one of the following (a-c):

    1. Confirmed by MRA, CTA or DSA that stenosis of intracranial aorta beyond 50% (in A2, M2 or P2)
    2. 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)
    3. ESRS score beyond 3
  6. Take Clopidogre or aspirin alone for antiplatelet treatment with informed consent
  7. Willing to participate in the clinical trial and willing to be followed up with, have signed informed consent

Exclusion criteria

Exclusion Criteria:

  1. Younger than 20 yrs or elder than 85 yrs;
  2. The neurological function defects caused by brain hemorrhage or other conditions (e.g. vascular malformations, tumors, abscesses or other non-ischemic cerebrovascular diseases);
  3. Isolated sensory symptoms (e.g. numbness), isolated visual abnormalities, isolated dizziness and dizziness but have no responsibility lesions in head MRI;
  4. Stroke is caused by angiography or surgery operation;
  5. Stroke caused by cardio-induced embolism according to TOAST;
  6. Anticoagulant evidence (heart thrombosis, such as atrial fibrillation, heart valve replacement surgery operation)
  7. Contraindications of MRI examination, such as claustrophobia or implanted pacemakers
  8. 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;
  9. 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
  10. History of drug elution coronary stent implantation within one year
  11. Congestive heart failure or uncontrolled Angina pectoris;
  12. Platelet reduction (platelet count less than 10000/mm3);
  13. Symptomatic non-traumatic intracranial bleeding, any other bleeding disorder, bleeding tendency or clotting dysfunction;
  14. History of gastrointestinal ulcers, gastrointestinal bleeding, or surgical history within the last 3 months;
  15. Severe complications of non-cardiovascular and life expectancy less than 3 months;
  16. Have malignant tumors which in course of treatment;
  17. History of allergies to SanqiTongshu;
  18. 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;
  19. Allergy history of clopidogrel;
  20. History of alcohol or drugs abuse in the past 12 months;
  21. Pregnant, lactating women, or women who do not take effective contraception;
  22. There are other serious diseases or abnormal laboratory results who is not suitable to participate the study;
  23. Those who are participating in other clinical trials or clinical trials completed in past 3 months;
  24. Patients do not understand the study, or are unable to/unwilling to follow the provisions of the clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    SanchiTongshu group

    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

    Drug: Sanchitongshu · Drug: Aspirin · Drug: Clopidogrel

  • Placebo comparator
    SanchiTongshu Placebo group

    Drug: placebo of Sanchitongshu The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch). Drug: Aspirin or Clopidogrel

    Drug: Aspirin · Drug: Clopidogrel · Drug: placebo of Sanchitongshu

Interventions

  • DrugSanchitongshu

    SanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd.

    Also known as: Radix/Rhizoma Notoginseng extract

  • Aspirin produced by Bayer Co., Ltd.

    Also known as: Bayaspirin Enteric-coated Tablets

  • Clopidogrel produced by Shenzhen Salubris Co., Ltd.

    Also known as: Clopidogrel Bisulfate

  • Drugplacebo of Sanchitongshu

    SanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. New stroke attack

    Any type of stroke events attack or recurrence

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2019 (actual). Primary completion is estimated for Dec 2020, 15 months after the start.

Of 569 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 15 months is below that.

Counting every sponsor, half of 652 studies reached it within 26 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2019
First posted
Oct 29, 2019
StartActual
Sep 1, 2019
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Oct 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04142151
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Sep 1, 2019
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Oct 29, 2019

Study contacts

Zhiyin Lou, Doctor
Contact
louzhiyin2003@163.com
86-021-25077504 ext. 8613611660696
Zhenguo Liu
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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