A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis

Study Overview
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Brief Summary
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This study investigates the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with moderate coronary stenosis for six months. At the same time, the studying will assess the plaque, myocardial blood-supplying,quality of life and observe the end point of the heart (including the myocardial revascularization, death and myocardial infarction). The purpose is to study the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever for moderate coronary stenosis lesions.

Detailed Description
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Blood-quickening stasis-transforming medicinal of Chinese medicinal can ameliorate clinical symptoms of coronary artery disease. Quick-Acting Heart Reliever is one of blood-quickening stasis-transforming medicinals to relieve angina pectoris in clinic and is especially benefit for the patients with moderate coronary stenosis who need not coronary revascularization only have medical treatment. But there is no randomized evidence that established the beneficial effects of blood-quickening stasis-transforming medicinals to treat moderate coronary stenosis lesions. This study is a randomized double-blind placebo-controlled clinical trials. A total of 120 consecutive participants with at least one moderate coronary stenosis lesion (diameter stenosis 50-75%) will be randomized to two groups: group 1(n =60) will receive Quick-Acting Heart and the placebo of isosorbide dinitrate, patients in group 2(n = 60) will receive isosorbide dinitrate and the placebo of Quick-Acting Heart for six months. The myocardial perfusion imaging and the coronary CT angiography will be used to evaluate the effective power of angina pectoris,myocardial blood-supplying，the quality and volume of the plaque, diameter stenosis after treating after 6 months and the end point of the heart (including death，myocardial infarction and myocardial revascularization which includes intracoronary stenting and coronary artery bypass grafting,) after 12 months. The purpose is to study the function of Quick-Acting Heart Reliever delaying percutaneous coronary intervention(PCI) for moderate coronary stenosis.

Official Title
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A Randomized Double-blind Placebo-controlled Clinical Trials of the Blood-quickening Stasis-transforming Formula Quick-Acting Heart Reliever for Patients With Moderate Coronary Stenosis

Conditions
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Coronary Artery Stenosis, Coronary Heart Disease

Intervention / Treatment
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* Drug: Quick-Acting Heart Reliever
* Drug: Isosorbide Dinitrate
* Drug: Placebo of Isosorbide Dinitrate
* Drug: Aspirin Enteric-coated Tablets
* Drug: Placebo of Quick-Acting Heart Reliever
* Drug: Aspirin Enteric-coated Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 30-75 years of age Angina or CAD patient Diameter stenosis 50-75% in at least one main coronary artery (Confirmed by coronary arteriography or coronary CT angiography) Not received percutaneous coronary intervention(PCI) Heart blood stasis obstruction syndrome according to TCM syndrome differentiation Provide written informed consent. Exclusion Criteria: Heart transplant or history of CABG or history of percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent. Left ventricular ejection fraction < 35% Acute myocardial infarction within 4 weeks prior to inclusion The contractive pressure > 160 mmHg or diastolic pressure >100 mmHg Severe valvular heart disease Insulin-dependent diabetes mellitus Serious heart, lung, liver, kidney and brain or other primary complications Mental patients Diagnosed or suspected tumor Allergic persons Pregnant, breastfeeding, or intends to become pregnant during the course of the study (females only) Patients not willing to or not able to give the informed consent to participate in the study The patients who are attending other clinical trial The person maybe loss for some reason such as work or life condition according to the investigator's judgement

Ages Eligible for Study
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Minimum Age: 30 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: Quick-Acting Heart Reliever group<br>Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets | Drug: Quick-Acting Heart Reliever<br>* Quick-Acting Heart Reliever，200mg，tid，po. for six months<br>* Other names: Suxiao Jiuxin Pill;Drug: Placebo of Isosorbide Dinitrate<br>* Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months<br>Drug: Aspirin Enteric-coated Tablets<br>* Aspirin Enteric-coated Tablets，100mg，qd，po. for six months<br>|
| Active Comparator: Isosorbide Dinitrate group<br>Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets | Drug: Isosorbide Dinitrate<br>* Isosorbide Dinitrate，10mg，tid，po. for six months<br>* Other names: Cedocard，Nitrosorbide， Vascardin;Drug: Placebo of Quick-Acting Heart Reliever<br>* Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months<br>Drug: Aspirin Enteric-coated Tablets<br>* Aspirin Enteric-coated Tablets，100mg，qd，po. for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effective power of angina pectoris | the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with morderate coronary stenosis for six months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque | Assess the plaque by the coronary CT angiography | 6 months | 
| myocardium blood-supply | Evaluate the myocardium blood-supply by the myocardial perfusion imaging | 6 months | 
| the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina) |  | 12 months | 
| symptoms score |  | 6 months | 
| quality of life |  | 6 months | 
| MMP-9 |  | 6 months | 
| SCD40L |  | 6 months | 
| VEGF |  | 6 months | 
| bFGF |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quick-Acting Heart Reliever, Coronary Artery Stenosis, Coronary Heart Disease, Suxiao Jiuxin Pill, Chinese Herbal Drugs, Traditional Chinese Medicine, Chinese Medicine, Angina Pectoris, Isosorbide Dinitrate, Myocardial Perfusion Imaging, Clinical Trial