Overview

This trial is active, not recruiting.

Conditions angina pectoris, coronary artery disease, coronary disease, heart disease, cardiovascular disease, chest pain, pain, signs and symptoms, arteriosclerosis
Sponsor Changchun University of Chinese Medicine
Start date April 2012
End date June 2013
Trial size 2 participants
Trial identifier NCT01715376, 201007001-3-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 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.

Primary Outcomes

Measure
Primary end point all cause death
time frame: up to 12 months
Secondary endpoint hospitalization
time frame: up to 12months

Secondary Outcomes

Measure
Angina symptoms
time frame: up to 12months
electrocardiogram
time frame: up to 12months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Changchun University of Chinese Medicine.