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

Phase 4

• Conditions: Coronary Artery Disease(CAD)
• Interventions: 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

• Registration Number: NCT03072121
• Lead Sponsor: Jun Li

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.

Study Timeline

• Study First Submitted: 2017-02-22
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04
• Study Start: 2017-06
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shexiang baoxin pill	Aspirin Enteric-coated Tablets	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)
Shexiang baoxin pill	Atorvastatin Calcium	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)
SBP placebo	Aspirin Enteric-coated 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)
SBP placebo	Atorvastatin Calcium	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)
SBP placebo	Isosorbide Mononitrate Tab 20 MG	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)
SBP placebo	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)
Shexiang baoxin pill	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)
Shexiang baoxin pill	Isosorbide Mononitrate Tab 20 MG	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)
Shexiang baoxin pill	Trimetazidine Dihydrochloride Tablets	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)
SBP placebo	Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet	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)
Shexiang baoxin pill	Metoprolol Tartrate Tab 25 MG	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)
Shexiang baoxin pill	Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet	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)
SBP placebo	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)
SBP placebo	Metoprolol Tartrate Tab 25 MG	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)

Primary Outcome Measures

Name	Time	Method
Mortality	Six months after randomisation	Death caused by cardiovascular disease

Secondary Outcome Measures

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