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

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ClinicalTrials.gov Identifier: NCT03072121
Recruitment Status : Unknown
Verified March 2017 by Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Shanghai Hutchison Pharmaceuticals Limited
Information provided by (Responsible Party):
Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease(CAD) Drug: Shexiang Baoxin pill Drug: SBP placebo Drug: Aspirin Enteric-coated Tablets Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet Drug: Atorvastatin Calcium Drug: Isosorbide Mononitrate Tab 20 MG Drug: Metoprolol Tartrate Tab 25 MG Drug: Trimetazidine Dihydrochloride Tablets Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Shexiang baoxin pill
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)
Drug: Shexiang Baoxin pill
Conventional western medicine & shexiang baoxin pill
Other Name: SBP

Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Other Name: Plavix

Drug: Atorvastatin Calcium
10 mg tablet, two tablets each night.
Other Name: Lipitor

Drug: Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Other Name: Xinkang

Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Other Name: Metoprolol

Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Other Name: Vasorel

Placebo Comparator: SBP placebo
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)
Drug: SBP placebo
Conventional western medicine & placebo (for shexiang baoxin pill)

Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Other Name: Plavix

Drug: Atorvastatin Calcium
10 mg tablet, two tablets each night.
Other Name: Lipitor

Drug: Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Other Name: Xinkang

Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Other Name: Metoprolol

Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Other Name: Vasorel




Primary Outcome Measures :
  1. Mortality [ Time Frame: Six months after randomisation ]
    Death caused by cardiovascular disease


Secondary Outcome Measures :
  1. Ejection fraction percentage (EF%) [ Time Frame: At baseline (before randomisation), and six months after randomisation. ]
    One of the Echocardiographic parameters

  2. E/A ratio [ Time Frame: At baseline (before randomisation), and six months after randomisation. ]
    One of the Echocardiographic parameters

  3. C-reactive protein (CRP) [ Time Frame: At baseline(before randomisation), and six months after randomisation. ]
    CRP in μg/L

  4. B-type natriuretic peptide (BNP) [ Time Frame: At baseline (before randomisation), and six months after randomisation. ]
    BNP in pg/mL

  5. Hospital readmission rates [ Time Frame: At baseline (before randomisation), and six months after randomisation. ]
    Hospital readmission rates due to coronary artery disease during treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072121


Contacts
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Contact: Jun Li, MD +86 13051458913 13051458913@163.com
Contact: Panpan Tian +86 15652388175 15652388175@163.com

Sponsors and Collaborators
Jun Li
Shanghai Hutchison Pharmaceuticals Limited
Investigators
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Study Director: Jie Wang, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Li, Director of Cardiology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03072121     History of Changes
Other Study ID Numbers: SBP-2016
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
coronary artery disease
revascularization
Shexiang Baoxin Pill
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Calcium, Dietary
Metoprolol
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Trimetazidine
Clopidogrel
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents