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Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization

Primary Purpose

Coronary Artery Disease(CAD)

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Shexiang Baoxin pill
SBP placebo
Aspirin Enteric-coated Tablets
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
Atorvastatin Calcium
Isosorbide Mononitrate Tab 20 MG
Metoprolol Tartrate Tab 25 MG
Trimetazidine Dihydrochloride Tablets
Sponsored by
Jun Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease(CAD) focused on measuring coronary artery disease, revascularization, Shexiang Baoxin Pill

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion Criteria:

  • Patients with severe valvular disease, congenital cardiomyopathy decompensation
  • Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
  • Patients that use high-dose steroids due to connective tissue disease
  • Patients with serious infections
  • Patients with malignant tumor
  • Patients with hematopoietic diseases
  • Pregnant or lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Shexiang baoxin pill

    SBP placebo

    Arm Description

    Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)

    Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)

    Outcomes

    Primary Outcome Measures

    Mortality
    Death caused by cardiovascular disease

    Secondary Outcome Measures

    Ejection fraction percentage (EF%)
    One of the Echocardiographic parameters
    E/A ratio
    One of the Echocardiographic parameters
    C-reactive protein (CRP)
    CRP in μg/L
    B-type natriuretic peptide (BNP)
    BNP in pg/mL
    Hospital readmission rates
    Hospital readmission rates due to coronary artery disease during treatment

    Full Information

    First Posted
    February 22, 2017
    Last Updated
    March 30, 2017
    Sponsor
    Jun Li
    Collaborators
    Shanghai Hutchison Pharmaceuticals Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03072121
    Brief Title
    Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization
    Official Title
    Study of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2017 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jun Li
    Collaborators
    Shanghai Hutchison Pharmaceuticals Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.
    Detailed Description
    The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years. Shexiang baoxin pill(SBP) is applicable to "Qi deficiency and blood stasis syndrome" in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease(CAD)
    Keywords
    coronary artery disease, revascularization, Shexiang Baoxin Pill

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    440 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shexiang baoxin pill
    Arm Type
    Experimental
    Arm Description
    Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
    Arm Title
    SBP placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
    Intervention Type
    Drug
    Intervention Name(s)
    Shexiang Baoxin pill
    Other Intervention Name(s)
    SBP
    Intervention Description
    Conventional western medicine & shexiang baoxin pill
    Intervention Type
    Drug
    Intervention Name(s)
    SBP placebo
    Intervention Description
    Conventional western medicine & placebo (for shexiang baoxin pill)
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin Enteric-coated Tablets
    Intervention Description
    100mg tablet, one tablet daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
    Other Intervention Name(s)
    Plavix
    Intervention Description
    one tablet daily. (for patients who can't use aspirin)
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin Calcium
    Other Intervention Name(s)
    Lipitor
    Intervention Description
    10 mg tablet, two tablets each night.
    Intervention Type
    Drug
    Intervention Name(s)
    Isosorbide Mononitrate Tab 20 MG
    Other Intervention Name(s)
    Xinkang
    Intervention Description
    1 tablet two times daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Metoprolol Tartrate Tab 25 MG
    Other Intervention Name(s)
    Metoprolol
    Intervention Description
    12.5 mg or 25 mg two times daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Trimetazidine Dihydrochloride Tablets
    Other Intervention Name(s)
    Vasorel
    Intervention Description
    20 mg tablet, one tablet three times daily.
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    Death caused by cardiovascular disease
    Time Frame
    Six months after randomisation
    Secondary Outcome Measure Information:
    Title
    Ejection fraction percentage (EF%)
    Description
    One of the Echocardiographic parameters
    Time Frame
    At baseline (before randomisation), and six months after randomisation.
    Title
    E/A ratio
    Description
    One of the Echocardiographic parameters
    Time Frame
    At baseline (before randomisation), and six months after randomisation.
    Title
    C-reactive protein (CRP)
    Description
    CRP in μg/L
    Time Frame
    At baseline(before randomisation), and six months after randomisation.
    Title
    B-type natriuretic peptide (BNP)
    Description
    BNP in pg/mL
    Time Frame
    At baseline (before randomisation), and six months after randomisation.
    Title
    Hospital readmission rates
    Description
    Hospital readmission rates due to coronary artery disease during treatment
    Time Frame
    At baseline (before randomisation), and six months after randomisation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome". Exclusion Criteria: Patients with severe valvular disease, congenital cardiomyopathy decompensation Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage Patients that use high-dose steroids due to connective tissue disease Patients with serious infections Patients with malignant tumor Patients with hematopoietic diseases Pregnant or lactating women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Li, MD
    Phone
    +86 13051458913
    Email
    13051458913@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Panpan Tian
    Phone
    +86 15652388175
    Email
    15652388175@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jie Wang, MD
    Organizational Affiliation
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27480425
    Citation
    Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese.
    Results Reference
    result
    PubMed Identifier
    20681275
    Citation
    Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese.
    Results Reference
    result
    PubMed Identifier
    27847338
    Citation
    Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12.
    Results Reference
    result
    PubMed Identifier
    20432394
    Citation
    Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431.
    Results Reference
    result
    PubMed Identifier
    20531008
    Citation
    Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53.
    Results Reference
    result
    PubMed Identifier
    23303884
    Citation
    Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
    Results Reference
    result
    PubMed Identifier
    22019563
    Citation
    Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
    Results Reference
    result
    PubMed Identifier
    29444778
    Citation
    Tian PP, Li J, Gao J, Li Y. Efficacy and safety of the Shexiang Baoxin Pill for the treatment of coronary artery disease not amenable to revascularisation: study protocol for a randomised, placebo-controlled, double-blinded trial. BMJ Open. 2018 Feb 14;8(2):e018052. doi: 10.1136/bmjopen-2017-018052.
    Results Reference
    derived

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    Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization

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