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

NCT01715376 | Completed DMC

• 1 other identifier: 201007001-3-1
• Study Type: observational
• Target: 1,042
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Primary end point all cause death

  all because of death, stroke, nonfatal myocardial infarction, revascularization.

  up to 12 months

• 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 Outcomes (2)

• Angina symptoms

  up to 12months

• electrocardiogram

  up to 12months

Other Outcomes (1)

• safety indicators

  up to 12months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

treat with combination of standardized western medical drug therapy and Chinese medical continued treatment

You may qualify if:

• the patients who are according with the II、III stage in CHD western medical diagnosis standard；
• age between 18 and 75(including 18 and 75)；
• Signed the informed consent voluntarily.

You may not qualify if:

• 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）；
• the patients who have myocardial infarction or vascular remodeling in last 3 months；
• hepatic and kidney function obstacle（ALT、AST\>1.5 times of normal upper limit value）；
• the patients who cannot control blood glucose properly（fasting blood glucose\>7.0mmol/L and/ or random blood glucose\>11.0mmol/L）；
• the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
• any other sever diseases such as malignant tumor；
• the patients who attending other clinical study in late 3 months；
• pregnant or lactating women；
• the patients who have allergic constitution or are allergic to many drugs.

Sponsors & Collaborators

• Changchun University of Chinese Medicine: lead

Study Sites (1)

Jilin Province TCM Institute of Chinese Medicine

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases

Study Officials

• deng yue

  dirctor

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiology department

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: October 29, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2015
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

CN (1)