Clinical trial NCT01715376: Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina Pectoris
Coronary Artery Disease
Coronary Disease
Heart Disease
Cardiovascular Disease
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Keywords: traditional chinese medicine
complementary therapies
traditional chinese medicine syndrome scale
Lead sponsor: Changchun University of Chinese Medicine
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 1042
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treat with combination of standardized western medical drug therapy and Chinese medical continued treatment

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.

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.

Primary outcomes:
measure: Primary end point all cause death
timeFrame: up to 12 months
measure: Secondary endpoint hospitalization
timeFrame: up to 12months
Secondary outcomes:
measure: Angina symptoms
timeFrame: up to 12months
measure: electrocardiogram
timeFrame: up to 12months
Other outcomes:
measure: safety indicators
timeFrame: up to 12months
Locations:
city: Changchun
country: China
facility: Jilin Province TCM Institute of Chinese Medicine
state: Jilin
Study officials:
affiliation: dirctor
name: deng yue
role: STUDY_CHAIR
References: