Coronary Heart DiseasePhase 2NCT03478332
Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
A Phase 2 study testing Yangxinshi pill and conventional coronary heart disease medicine in people with Coronary Heart Disease, run by Affiliated Hospital of Changchun University of Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Yangxinshi pill and conventional coronary heart disease medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 25 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changchun Traditional Medicine University Affiliated Hospital
Changchun, Jilin, 130021
Xiaoping Meng, Doctor, 8618994127461, 18994127461@163.com
About this study
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
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
Read the 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).
- Conditions
- Coronary Heart Disease
- Being tested
- Yangxinshi pill, conventional coronary heart disease medicine, Placebos
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxinshi pillDrug
Also called STATE MEDICAL PERMISSION No.Z37021103
0.6g/tablet
conventional coronary heart disease medicineDrug
Also called glyceryl trinitrate， beta-Blocking agent，etc
the conventional treatment includes medicines treating coronary heart disease
PlacebosDrug
Also called Yangxinshi simulant
Yangxinshi simulant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Yangxinshi pill; Drug: 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 Receives: Drug: conventional coronary heart disease medicine; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the maximum volume of O2 consumption
measured by gas analyzer
Measured: from baseline to 6 months
Secondary outcomes (2)
change in exercise tolerance
assessed by the distance (in meters) walked on 6-minute walk test
Measured: from baseline to 6 months
change in left ventricular ejection fraction (in percentage)
assessed by echocardiographic examination
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jun 2017
- Primary completion2 May 2020 (estimated)
- Study completion25 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Changchun University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Meng, Affiliated Hospital of Changchun University of Chinese Medicine
- Investigators
- Xiaoping Meng, Doctor, Principal investigator, Changchun Traditional Medicine University Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478332
- Sponsor's protocol ID
- GFH-C04
- Status last verified
- Mar 2018
- First submitted
- 11 Feb 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03478332
- Acronym / sponsor ID
- GFH-C04
- Conditions
- Coronary Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Changchun University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 25 Aug 2020 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Yangxinshi pill, Drug: conventional coronary heart disease medicineThe 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 |
| Control group | Placebo comparator | Drug: conventional coronary heart disease medicine, Drug: PlacebosThe patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yangxinshi pillAlso: STATE MEDICAL PERMISSION No.Z370211030.6g/tablet | Drug | Treatment group |
| conventional coronary heart disease medicineAlso: glyceryl trinitrate， beta-Blocking agent，etcthe conventional treatment includes medicines treating coronary heart disease | Drug | Control group, Treatment group |
| PlacebosAlso: Yangxinshi simulantYangxinshi simulant | Drug | Control group |
Primary outcome
change in the maximum volume of O2 consumption
Time frame: from baseline to 6 months
measured by gas analyzer
2 secondary outcomes
change in exercise tolerance
Time frame: from baseline to 6 months
change in left ventricular ejection fraction (in percentage)
Time frame: from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Meng, Doctor principal investigator
Changchun Traditional Medicine University Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yangxinshi pill and conventional coronary heart disease medicine in people with Coronary Heart Disease, run by Affiliated Hospital of Changchun University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Meng, Doctor (8618994127461, 18994127461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the maximum volume of O2 consumption (time frame: from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.