Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Stable Angina Pectoris

Study Overview
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Brief Summary
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This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.

Detailed Description
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A total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus Dun Ye Guan Xin Ning tablet for 6 months. Symptoms, questionnaires (SAQ, PSQI, and angina pectoris quantitative table of Chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, EKG, blood pressure and other physical examination will be collected at baseline and follow-up. Among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.

Official Title
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An Open Label, Single Arm, Multiple Center Study Observing the Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Coronary Artery Disease of Angina Pectoris

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Dun Ye Guan Xin Ning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 75 years. Documented stable angina pectoris. During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable. Patients with at least one of the following events: ① patients who have done PCI or CABG for more than half a year; ② coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. Symptom occurs at least once per month. Medications remain stable within 1 month before the enrollment. Patients have the ability to understand the study, and can cooperate with researchers to carry out the test. Signed inform consent. Exclusion Criteria: Patents with coronary heart disease acute coronary syndrome during the last 6 months. Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina. Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain. Patients combined with severe cardiopulmonary insufficiency (NYHA grade III ord IV), pulmonary insufficiency graded reference COPD clinical severity of lung function grade III (FEV1 / FVC <70%, 30% 1 / FVC% of predicted value <50%) and grade IV), severe arrhythmia (eg. III degree atrioventricular block) Patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (TBil ≥ 1.5ULN, AST ≥ 2ULN, ALT ≥ 2ULN, serum creatinine ≥ 1.5ULN, Hb <9mg/dL). Patients with cognitive, intellectual, or mental disorders. Those who can not take oral medication. Allergy to any component of this product. Patients received the trial medication within 28 days prior to the first treatment of this product. Lactating or pregnant women. Patients who are unwilling or unable to contraceptive in the reproductive period. Poor medication compliance. Other circumstances that the investigator considers unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dun Ye Guan Xin Ning mono-therapy<br> | Drug: Dun Ye Guan Xin Ning<br>* Dun Ye Guan Xin Ning tablet 320 mg orally every time and 3 times per day for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angina pectoris symptom | Improvement od angina pectoris symptom | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality | using seattle Angina Questionnaire | 6 month | 
| Sleep quality | using pittsburgh sleep quality index | 6 month | 
| Chest tightness | using angina pectoris quantitative table of Chinese medicine symptoms | 0, 1 month, 3 month, 6 month | 
| Biomarkers | levels of TG，TC, LDL, HDL, HCY, IL-6、TNF-α、and CRP | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable angina pectoris, Dun Ye Guan Xin Ning