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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Dun Ye Guan Xin Ning

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhang, MD; Phone Number: 8610-83575728; Email: drzhy1108@163.com
• Study Contact Backup: Name: Yong Huo, MD; Phone Number: 8610-83572283; Email: huoyong@263.net.cn

Study Locations

• China
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
    • Contact: Yan Zhang, MD; Phone Number: 8610-83575728; Email: drzhy1108@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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: 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dun Ye Guan Xin Ning mono-therapy	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular endothelial function	using ZX7M-Endo-pat2000	0, 1 month, 3 month, 6 month

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: stable angina pectoris; Dun Ye Guan Xin Ning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: DY-SH-1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No