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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198091
• Other study ID #: DY-SH-1601
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: June 21, 2017
• Start date: March 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: Peking University First Hospital
• Contact: Yong Huo, MD
• Phone: 8610-83572283
• Email: huoyong[@]263.net.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 75 years.

2. Documented stable angina pectoris.

3. During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable.

4. Patients with at least one of the following events: ? patients who have done PCI or CABG for more than half a year; ? coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis = 50%. Symptom occurs at least once per month.

5. Medications remain stable within 1 month before the enrollment.

6. Patients have the ability to understand the study, and can cooperate with researchers to carry out the test.

7. Signed inform consent.

Exclusion Criteria:

1. Patents with coronary heart disease acute coronary syndrome during the last 6 months.

2. Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina.

3. Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain.

4. 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)

5. 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).

6. Patients with cognitive, intellectual, or mental disorders.

7. Those who can not take oral medication.

8. Allergy to any component of this product.

9. Patients received the trial medication within 28 days prior to the first treatment of this product.

10. Lactating or pregnant women.

11. Patients who are unwilling or unable to contraceptive in the reproductive period.

12. Poor medication compliance.

13. Other circumstances that the investigator considers unsuitable for inclusion.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Dun Ye Guan Xin Ning
Dun Ye Guan Xin Ning tablet 320 mg orally every time and 3 times per day for 6 months.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular endothelial function	using ZX7M-Endo-pat2000	0, 1 month, 3 month, 6 month
Primary	Angina pectoris symptom	Improvement od angina pectoris symptom	6 month
Secondary	Life quality	using seattle Angina Questionnaire	6 month
Secondary	Sleep quality	using pittsburgh sleep quality index	6 month
Secondary	Chest tightness	using angina pectoris quantitative table of Chinese medicine symptoms	0, 1 month, 3 month, 6 month
Secondary	Biomarkers	levels of TG,TC, LDL, HDL, HCY, IL-6?TNF-a?and CRP	6 month