Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events

Study Overview
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Brief Summary
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Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.

Detailed Description
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We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.

Official Title
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Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Conditions
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Chest Pain, Angina Pectoris, Coronary Artery Disease, Coronary Disease, Heart Disease, Cardiovascular Disease, Pain, Signs and Symptoms, Arteriosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients who are according with the II、III stage in CHD western medical diagnosis standard； age between 18 and 75(including 18 and 75)； Signed the informed consent voluntarily. Exclusion Criteria: The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）； the patients who have myocardial infarction or vascular remodeling in last 3 months； hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）； the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）； the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）； any other sever diseases such as malignant tumor； the patients who attending other clinical study in late 3 months； pregnant or lactating women； the patients who have allergic constitution or are allergic to many drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrative Chinese and western medicine<br>Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study. | |
| Western medicine<br>western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point all cause death | all because of death, stroke, nonfatal myocardial infarction, revascularization. | up to 12 months | 
| Secondary endpoint hospitalization | the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications | up to 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angina symptoms | Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin. | up to 12months | 
| electrocardiogram |  | up to 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traditional chinese medicine, complementary therapies, traditional chinese medicine syndrome scale