NCT03198091

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

May 25, 2017

Last Update Submit

June 21, 2017

Conditions

Coronary Heart Disease

Keywords

stable angina pectorisDun Ye Guan Xin Ning

Outcome Measures

Primary Outcomes (1)

  • Angina pectoris symptom

    Improvement od angina pectoris symptom

    6 month

Secondary Outcomes (4)

  • Life quality

    6 month

  • Sleep quality

    6 month

  • Chest tightness

    0, 1 month, 3 month, 6 month

  • Biomarkers

    6 month

Other Outcomes (1)

  • Vascular endothelial function

    0, 1 month, 3 month, 6 month

Study Arms (1)

Dun Ye Guan Xin Ning mono-therapy

EXPERIMENTAL
Drug: Dun Ye Guan Xin Ning

Interventions

Dun Ye Guan Xin NingDRUG

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

Dun Ye Guan Xin Ning mono-therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseAngina, Stable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yong Huo, MD

CONTACT

8610-83572283huoyong@263.net.cn

Yan Zhang, MD

CONTACT

8610-83575728drzhy1108@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Cardiology and heart center of Peking University First Hospital

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 23, 2017

Study Start

March 30, 2017

Primary Completion

June 1, 2018

Study Completion

December 31, 2018

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)