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

Completed

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

• Registration Number: NCT01715376
• Lead Sponsor: Changchun University of Chinese Medicine

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-29
• Primary Completion: 2013-09
• Study Completion: 2015-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1042

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
electrocardiogram	up to 12months
Angina symptoms	up to 12months	Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.

Trial Locations

Locations (1)

Jilin Province TCM Institute of Chinese Medicine; 🇨🇳 Changchun, Jilin, China