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

NCT ID: NCT01715376

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1042 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Integrative Chinese and western medicine

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.

No interventions assigned to this group

Western medicine

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changchun University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

yue deng

Director of cardiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

deng yue

Role: STUDY_CHAIR

dirctor

Locations

Jilin Province TCM Institute of Chinese Medicine

Changchun, Jilin, China

Countries

China

Other Identifiers

201007001-3-1

Identifier Type: -

Identifier Source: org_study_id