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Completed

NCT Number: NCT01715376

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jilin Province TCM Institute of Chinese Medicine

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Primary end point all cause death

    Time frame: up to 12 months

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

  2. Secondary endpoint hospitalization

    Time frame: up to 12months

    the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications

Secondary outcomes

  1. Angina symptoms

    Time frame: up to 12months

    Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.

  2. electrocardiogram

    Time frame: up to 12months

Other outcomes

  1. safety indicators

    Time frame: up to 12months

    ALT ,AST,BUN,CR,blood routine examination,urine routine

Sponsors and collaborators

Lead sponsor

Changchun University of Chinese Medicine

Other

Registry information

Official study title

Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 29, 2012
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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