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

NCT ID: NCT04142151

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Sanchitongshu

Intervention Type: DRUG

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

Aspirin

Intervention Type: DRUG

Aspirin produced by Bayer Co., Ltd.

Clopidogrel

Intervention Type: DRUG

Clopidogrel produced by Shenzhen Salubris Co., Ltd.

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

Group Type: PLACEBO_COMPARATOR

Aspirin

Intervention Type: DRUG

Aspirin produced by Bayer Co., Ltd.

Clopidogrel

Intervention Type: DRUG

Clopidogrel produced by Shenzhen Salubris Co., Ltd.

placebo of Sanchitongshu

Intervention Type: DRUG

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

Interventions

Sanchitongshu

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

Intervention Type: DRUG

Aspirin

Aspirin produced by Bayer Co., Ltd.

Intervention Type: DRUG

Clopidogrel

Clopidogrel produced by Shenzhen Salubris Co., Ltd.

Intervention Type: DRUG

placebo of Sanchitongshu

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

Intervention Type: DRUG

Other Intervention Names

Radix/Rhizoma Notoginseng extract; Bayaspirin Enteric-coated Tablets; Clopidogrel Bisulfate; Placebo

Eligibility Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenguo Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Zhenguo Liu

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiyin Lou, Doctor

Role: CONTACT

louzhiyin2003@163.com

86-021-25077504 ext. 8613611660696

Facility Contacts

Zhenguo Liu

Role: primary

zhenguoliu2004@aliyun.com

8602125077501 ext. 8602125077501

Zhiyin Lou

Role: backup

louzhiyin2003@163.com

8602125077504 ext. 8602125077504

Other Identifiers

XH-19-007

Identifier Type: -

Identifier Source: org_study_id