Clinical trial NCT03478332: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Heart Disease
Lead sponsor: Affiliated Hospital of Changchun University of Chinese Medicine
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).

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

Primary outcomes:
measure: change in the maximum volume of O2 consumption
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: change in exercise tolerance
timeFrame: from baseline to 6 months
measure: change in left ventricular ejection fraction (in percentage)
timeFrame: from baseline to 6 months
Other outcomes:
measure: Adverse events
timeFrame: 24 months
Locations:
city: Chang Chun
country: China
facility: Changchun Traditional Medicine University Affiliated Hospital
state: Ji Lin
Study officials:
affiliation: Changchun Traditional Medicine University Affiliated Hospital
name: Xiaoping Meng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: