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

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dun Ye Guan Xin Ning

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring stable angina pectoris, Dun Ye Guan Xin Ning

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dun Ye Guan Xin Ning mono-therapy

Arm Description

Outcomes

Primary Outcome Measures

Angina pectoris symptom

Improvement od angina pectoris symptom

Secondary Outcome Measures

Life quality

using seattle Angina Questionnaire

Sleep quality

using pittsburgh sleep quality index

Chest tightness

using angina pectoris quantitative table of Chinese medicine symptoms

Biomarkers

levels of TG，TC, LDL, HDL, HCY, IL-6、TNF-α、and CRP

Full Information

NCT ID

NCT03198091

First Posted

May 25, 2017

Last Updated

June 21, 2017

Sponsor

Peking University First Hospital

Collaborators

Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03198091

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 30, 2017 (Actual)

Primary Completion Date

June 1, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

Collaborators

Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

stable angina pectoris, Dun Ye Guan Xin Ning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dun Ye Guan Xin Ning mono-therapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dun Ye Guan Xin Ning

Intervention Description

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

Primary Outcome Measure Information:

Title

Angina pectoris symptom

Description

Improvement od angina pectoris symptom

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Life quality

Description

using seattle Angina Questionnaire

Time Frame

6 month

Title

Sleep quality

Description

using pittsburgh sleep quality index

Time Frame

6 month

Title

Chest tightness

Description

using angina pectoris quantitative table of Chinese medicine symptoms

Time Frame

0, 1 month, 3 month, 6 month

Title

Biomarkers

Description

levels of TG，TC, LDL, HDL, HCY, IL-6、TNF-α、and CRP

Time Frame

6 month

Other Pre-specified Outcome Measures:

Title

Vascular endothelial function

Description

using ZX7M-Endo-pat2000

Time Frame

0, 1 month, 3 month, 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Huo, MD

Phone

8610-83572283

huoyong@263.net.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhang, MD

Phone

8610-83575728

drzhy1108@163.com

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Zhang, MD

Phone

8610-83575728

drzhy1108@163.com

First Name & Middle Initial & Last Name & Degree

Yan Zhang, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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