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

NCT04142151 | Unknown

• 1 other identifier: XH-19-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Stroke; Antiplatelet Effect

Keywords

Ischemic stroke, Sanchitongshu, Aspirin, Clopidogrel

Outcome Measures

Primary Outcomes (1)

• New stroke attack

  Any type of stroke events attack or recurrence

  24 hours

Study Arms (2)

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

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

Drug: Aspirin; Drug: Clopidogrel; Drug: placebo of Sanchitongshu

Interventions

Sanchitongshu DRUG

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

Also known as: Radix/Rhizoma Notoginseng extract

SanchiTongshu group

Aspirin DRUG

Aspirin produced by Bayer Co., Ltd.

Also known as: Bayaspirin Enteric-coated Tablets

SanchiTongshu Placebo group; SanchiTongshu group

Clopidogrel DRUG

Clopidogrel produced by Shenzhen Salubris Co., Ltd.

Also known as: Clopidogrel Bisulfate

SanchiTongshu Placebo group; SanchiTongshu group

placebo of Sanchitongshu DRUG

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

SanchiTongshu Placebo group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)
• 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;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Zhenguo Liu

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhenguo Liu

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyin Lou, Doctor

CONTACT

86-021-25077504; louzhiyin2003@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-09

Locations

CN (1)