Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease

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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Yangxinshi pill; Drug: conventional coronary heart disease medicine; Drug: Placebos

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:

1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
3. The maximum walking distance of 6-minute walk test;
4. Changes of Seattle Angina Questionnaire;
5. Hamilton Depression Scale/ Hamilton Anxiety Scale.

The safety evaluation criteria is:

1. Adverse event and serious adverse event;
2. Vital signs;
3. Resting 12 lead ECG;
4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Ji Lin
    • Chang Chun, Ji Lin, China, 130021
      • Recruiting
      • Changchun Traditional Medicine University Affiliated Hospital
      • Contact: Xiaoping Meng, Doctor; Phone Number: 8618994127461; Email: 18994127461@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group; 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	Drug: Yangxinshi pill; 0.6g/tablet; Other Names: STATE MEDICAL PERMISSION No.Z37021103; Drug: conventional coronary heart disease medicine; the conventional treatment includes medicines treating coronary heart disease; Other Names: glyceryl trinitrate， beta-Blocking agent，etc
Placebo Comparator: Control group; The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant	Drug: conventional coronary heart disease medicine; the conventional treatment includes medicines treating coronary heart disease; Other Names: glyceryl trinitrate， beta-Blocking agent，etc; Drug: Placebos; Yangxinshi simulant; Other Names: Yangxinshi simulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the maximum volume of O2 consumption	measured by gas analyzer	from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in exercise tolerance	assessed by the distance (in meters) walked on 6-minute walk test	from baseline to 6 months
change in left ventricular ejection fraction (in percentage)	assessed by echocardiographic examination	from baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of treatment-related adverse events as assessed by CTCAE4.0	24 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Changchun University of Chinese Medicine
• Investigators: Principal Investigator: Xiaoping Meng, Doctor, Changchun Traditional Medicine University Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 2, 2020
• Study Completion (Anticipated): August 25, 2020

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: GFH-C04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No