Back to resultsEffects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yangxinshi pill
conventional coronary heart disease medicine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- Age 40 ~ 75, gender is not limited
- Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
- Sign the informed consent voluntarily
Exclusion Criteria:
- History of hospitalization for acute coronary syndrome in past 3 months
- Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg）
- History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
- In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
- Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block
- Severely allergic constitution, known or likely to be allergic to the test drug or its components
- Known bleeding tendency or hemorrhagic disease
- Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
- Any other situations that researchers believe may affect the clinical research
Sites / Locations
- Changchun Traditional Medicine University Affiliated HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
Outcomes
Primary Outcome Measures
change in the maximum volume of O2 consumption
measured by gas analyzer
Secondary Outcome Measures
change in exercise tolerance
assessed by the distance (in meters) walked on 6-minute walk test
change in left ventricular ejection fraction (in percentage)
assessed by echocardiographic examination
Full Information
NCT ID
NCT03478332
First Posted
February 11, 2018
Last Updated
March 20, 2018
Sponsor
Affiliated Hospital of Changchun University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03478332
Brief Title
Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
Official Title
Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 2, 2020 (Anticipated)
Study Completion Date
August 25, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Changchun University of Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health
Detailed Description
90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.
One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.
The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.
The secondary endpoint is:
Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
The maximum walking distance of 6-minute walk test;
Changes of Seattle Angina Questionnaire;
Hamilton Depression Scale/ Hamilton Anxiety Scale.
The safety evaluation criteria is:
Adverse event and serious adverse event;
Vital signs;
Resting 12 lead ECG;
Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
Intervention Type
Drug
Intervention Name(s)
Yangxinshi pill
Other Intervention Name(s)
STATE MEDICAL PERMISSION No.Z37021103
Intervention Description
0.6g/tablet
Intervention Type
Drug
Intervention Name(s)
conventional coronary heart disease medicine
Other Intervention Name(s)
glyceryl trinitrate， beta-Blocking agent，etc
Intervention Description
the conventional treatment includes medicines treating coronary heart disease
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Yangxinshi simulant
Intervention Description
Yangxinshi simulant
Primary Outcome Measure Information:
Title
change in the maximum volume of O2 consumption
Description
measured by gas analyzer
Time Frame
from baseline to 6 months
Secondary Outcome Measure Information:
Title
change in exercise tolerance
Description
assessed by the distance (in meters) walked on 6-minute walk test
Time Frame
from baseline to 6 months
Title
change in left ventricular ejection fraction (in percentage)
Description
assessed by echocardiographic examination
Time Frame
from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Number of treatment-related adverse events as assessed by CTCAE4.0
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 40 ~ 75, gender is not limited
Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
Sign the informed consent voluntarily
Exclusion Criteria:
History of hospitalization for acute coronary syndrome in past 3 months
Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg）
History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block
Severely allergic constitution, known or likely to be allergic to the test drug or its components
Known bleeding tendency or hemorrhagic disease
Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
Any other situations that researchers believe may affect the clinical research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Meng, Doctor
Phone
8618994127461
Email
18994127461@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Meng, Doctor
Organizational Affiliation
Changchun Traditional Medicine University Affiliated Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changchun Traditional Medicine University Affiliated Hospital
City
Chang Chun
State/Province
Ji Lin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Meng, Doctor
Phone
8618994127461
Email
18994127461@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
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