Overview

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

Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University First Hospital
Collaborator:
Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.
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.