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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy

Conditions
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Coronary Artery Disease(CAD)

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shexiang baoxin pill<br>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<br>* Conventional western medicine & shexiang baoxin pill<br>* Other names: SBP;Drug: Aspirin Enteric-coated Tablets<br>* 100mg tablet, one tablet daily.<br>Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet<br>* one tablet daily. (for patients who can't use aspirin)<br>* Other names: Plavix;Drug: Atorvastatin Calcium<br>* 10 mg tablet, two tablets each night.<br>* Other names: Lipitor;Drug: Isosorbide Mononitrate Tab 20 MG<br>* 1 tablet two times daily.<br>* Other names: Xinkang;Drug: Metoprolol Tartrate Tab 25 MG<br>* 12.5 mg or 25 mg two times daily.<br>* Other names: Metoprolol;Drug: Trimetazidine Dihydrochloride Tablets<br>* 20 mg tablet, one tablet three times daily.<br>* Other names: Vasorel;|
| Placebo Comparator: SBP placebo<br>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<br>* Conventional western medicine & placebo (for shexiang baoxin pill)<br>Drug: Aspirin Enteric-coated Tablets<br>* 100mg tablet, one tablet daily.<br>Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet<br>* one tablet daily. (for patients who can't use aspirin)<br>* Other names: Plavix;Drug: Atorvastatin Calcium<br>* 10 mg tablet, two tablets each night.<br>* Other names: Lipitor;Drug: Isosorbide Mononitrate Tab 20 MG<br>* 1 tablet two times daily.<br>* Other names: Xinkang;Drug: Metoprolol Tartrate Tab 25 MG<br>* 12.5 mg or 25 mg two times daily.<br>* Other names: Metoprolol;Drug: Trimetazidine Dihydrochloride Tablets<br>* 20 mg tablet, one tablet three times daily.<br>* Other names: Vasorel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death caused by cardiovascular disease | Six months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction percentage (EF%) | One of the Echocardiographic parameters | At baseline (before randomisation), and six months after randomisation. | 
| E/A ratio | One of the Echocardiographic parameters | At baseline (before randomisation), and six months after randomisation. | 
| C-reactive protein (CRP) | CRP in μg/L | At baseline(before randomisation), and six months after randomisation. | 
| B-type natriuretic peptide (BNP) | BNP in pg/mL | At baseline (before randomisation), and six months after randomisation. | 
| Hospital readmission rates | Hospital readmission rates due to coronary artery disease during treatment | At baseline (before randomisation), and six months after randomisation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, revascularization, Shexiang Baoxin Pill