NCT03478332

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

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2017

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

February 11, 2018

Last Update Submit

March 20, 2018

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • change in the maximum volume of O2 consumption

    measured by gas analyzer

    from baseline to 6 months

Secondary Outcomes (2)

  • change in exercise tolerance

    from baseline to 6 months

  • change in left ventricular ejection fraction (in percentage)

    from baseline to 6 months

Other Outcomes (1)

  • Adverse events

    24 months

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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 pillDrug: conventional coronary heart disease medicine

Control group

PLACEBO COMPARATOR

The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant

Drug: conventional coronary heart disease medicineDrug: Placebos

Interventions

Yangxinshi pillDRUG

0.6g/tablet

Also known as: STATE MEDICAL PERMISSION No.Z37021103
Treatment group
conventional coronary heart disease medicineDRUG

the conventional treatment includes medicines treating coronary heart disease

Also known as: glyceryl trinitrate， beta-Blocking agent，etc
Control groupTreatment group
PlacebosDRUG

Yangxinshi simulant

Also known as: Yangxinshi simulant
Control group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changchun Traditional Medicine University Affiliated Hospital

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Interventions

Yangxinshi

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Xiaoping Meng, Doctor

    Changchun Traditional Medicine University Affiliated Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoping Meng, Doctor

CONTACT

861899412746118994127461@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

February 11, 2018

First Posted

March 27, 2018

Study Start

June 1, 2017

Primary Completion

May 2, 2020

Study Completion

August 25, 2020

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

CN(1)