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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715376
• Other study ID #: 201007001-3-1
• Status: Completed
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2020
• Source: Changchun University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: June 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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??degree), 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Jilin Province TCM Institute of Chinese Medicine	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Changchun University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety indicators	ALT ,AST,BUN,CR,blood routine examination,urine routine	up to 12months
Primary	Primary end point all cause death	all because of death, stroke, nonfatal myocardial infarction, revascularization.	up to 12 months
Primary	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	Angina symptoms	Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.	up to 12months
Secondary	electrocardiogram		up to 12months