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

Changchun University of Chinese Medicine1,042 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,042

Conditions

Angina Pectoris Coronary Artery Disease Coronary Disease Heart Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. the patients who are according with the II、III stage in CHD western medical diagnosis standard； 2. age between 18 and 75(including 18 and 75)； 3. Signed the informed consent voluntarily. Exclusion Criteria: 1. 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）； 2. the patients who have myocardial infarction or vascular remodeling in last 3 months； 3. hepatic and kidney function obstacle（ALT、AST\>1.5 times of normal upper limit value）； 4. the patients who cannot control blood glucose properly（fasting blood glucose\>7.0mmol/L and/ or random blood glucose\>11.0mmol/L）； 5. the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）； 6. any other sever diseases such as malignant tumor； 7. the patients who attending other clinical study in late 3 months； 8. pregnant or lactating women； 9. the patients who have allergic constitution or are allergic to many drugs.

Outcomes

Primary Outcomes

Primary end point all cause death

all because of death, stroke, nonfatal myocardial infarction, revascularization.

Time frame: 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

Time frame: up to 12months

Secondary Outcomes

Angina symptoms

Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.

Time frame: up to 12months

electrocardiogram

Time frame: up to 12months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes