Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Changchun University of Chinese Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
yue deng, Changchun University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01715376
First received: September 14, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Changchun University of Chinese Medicine:

Primary Outcome Measures:
  • Primary end point all cause death [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    all because of death, stroke, nonfatal myocardial infarction, revascularization.

  • Secondary endpoint hospitalization [ Time Frame: up to 12months ] [ Designated as safety issue: No ]
    the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications


Secondary Outcome Measures:
  • Angina symptoms [ Time Frame: up to 12months ] [ Designated as safety issue: No ]
    Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.

  • electrocardiogram [ Time Frame: up to 12months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • safety indicators [ Time Frame: up to 12months ] [ Designated as safety issue: No ]
    ALT ,AST,BUN,CR,blood routine examination,urine routine


Estimated Enrollment: 2
Study Start Date: April 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715376

Locations
China, Jilin
Jilin Province TCM Institute of Chinese Medicine
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Changchun University of Chinese Medicine
Investigators
Study Chair: deng yue dirctor
  More Information

No publications provided

Responsible Party: yue deng, Director of cardiology department, Changchun University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01715376     History of Changes
Other Study ID Numbers: 201007001-3-1
Study First Received: September 14, 2012
Last Updated: October 26, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Changchun University of Chinese Medicine:
traditional chinese medicine
complementary therapies
traditional chinese medicine syndrome scale

Additional relevant MeSH terms:
Angina Pectoris
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Signs and Symptoms
Arterial Occlusive Diseases
Pain
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014