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

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ClinicalTrials.gov Identifier: NCT03198091
Recruitment Status : Unknown
Verified June 2017 by Yong Huo, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Dun Ye Guan Xin Ning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Angina pectoris symptom [ Time Frame: 6 month ]
    Improvement od angina pectoris symptom


Secondary Outcome Measures :
  1. Life quality [ Time Frame: 6 month ]
    using seattle Angina Questionnaire

  2. Sleep quality [ Time Frame: 6 month ]
    using pittsburgh sleep quality index

  3. Chest tightness [ Time Frame: 0, 1 month, 3 month, 6 month ]
    using angina pectoris quantitative table of Chinese medicine symptoms

  4. Biomarkers [ Time Frame: 6 month ]
    levels of TG,TC, LDL, HDL, HCY, IL-6、TNF-α、and CRP


Other Outcome Measures:
  1. Vascular endothelial function [ Time Frame: 0, 1 month, 3 month, 6 month ]
    using ZX7M-Endo-pat2000



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198091


Contacts
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Contact: Yong Huo, MD 8610-83572283 huoyong@263.net.cn
Contact: Yan Zhang, MD 8610-83575728 drzhy1108@163.com

Locations
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China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Yan Zhang, MD    8610-83575728    drzhy1108@163.com   
Principal Investigator: Yan Zhang, MD         
Sponsors and Collaborators
Peking University First Hospital
Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.

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Responsible Party: Yong Huo, Director of the Department of Cardiology and heart center of Peking University First Hospital, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03198091     History of Changes
Other Study ID Numbers: DY-SH-1601
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yong Huo, Peking University First Hospital:
stable angina pectoris
Dun Ye Guan Xin Ning
Additional relevant MeSH terms:
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Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases