Coronary Heart DiseaseNCT03198091
Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Stable Angina Pectoris
A study testing Dun Ye Guan Xin Ning in people with Coronary Heart Disease, run by Peking University First Hospital at 1 site in China.
Trial summary
This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Dun Ye Guan Xin Ning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years.
- Documented stable angina pectoris.
- During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable.
- Patients with at least one of the following events: ① patients who have done PCI or CABG for more than half a year; ② coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. Symptom occurs at least once per month.
- Medications remain stable within 1 month before the enrollment.
- Patients have the ability to understand the study, and can cooperate with researchers to carry out the test.
- Signed inform consent.
Who cannot join
- Patents with coronary heart disease acute coronary syndrome during the last 6 months.
- Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina.
- Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain.
- Patients combined with severe cardiopulmonary insufficiency (NYHA grade III ord IV), pulmonary insufficiency graded reference COPD clinical severity of lung function grade III (FEV1 / FVC <70%, 30% 1 / FVC% of predicted value <50%) and grade IV), severe arrhythmia (eg. III degree atrioventricular block)
- Patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (TBil ≥ 1.5ULN, AST ≥ 2ULN, ALT ≥ 2ULN, serum creatinine ≥ 1.5ULN, Hb <9mg/dL).
- Patients with cognitive, intellectual, or mental disorders.
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- Those who can not take oral medication.
- Allergy to any component of this product.
- Patients received the trial medication within 28 days prior to the first treatment of this product.
- Lactating or pregnant women.
- Patients who are unwilling or unable to contraceptive in the reproductive period.
- Poor medication compliance.
- Other circumstances that the investigator considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Yan Zhang, MD, 8610-83575728, drzhy1108@163.com
Yan Zhang, MD
About this study
Official title: An Open Label, Single Arm, Multiple Center Study Observing the Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Coronary Artery Disease of Angina Pectoris
This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.
Read the detailed description
A total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus Dun Ye Guan Xin Ning tablet for 6 months. Symptoms, questionnaires (SAQ, PSQI, and angina pectoris quantitative table of Chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, EKG, blood pressure and other physical examination will be collected at baseline and follow-up. Among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.
- Conditions
- Coronary Heart Disease
- Being tested
- Dun Ye Guan Xin Ning
- Keywords
- stable angina pectoris, Dun Ye Guan Xin Ning
- Medical subject headings
- Coronary Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dun Ye Guan Xin NingDrug
Dun Ye Guan Xin Ning tablet 320 mg orally every time and 3 times per day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Dun Ye Guan Xin Ning mono-therapy | Experimental | Not described Receives: Drug: Dun Ye Guan Xin Ning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angina pectoris symptom
Improvement od angina pectoris symptom
Measured: 6 month
Secondary outcomes (4)
Life quality
using seattle Angina Questionnaire
Measured: 6 month
Sleep quality
using pittsburgh sleep quality index
Measured: 6 month
Chest tightness
using angina pectoris quantitative table of Chinese medicine symptoms
Measured: 0, 1 month, 3 month, 6 month
Biomarkers
levels of TG，TC, LDL, HDL, HCY, IL-6、TNF-α、and CRP
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start30 Mar 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion31 Dec 2018 (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.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198091
- Sponsor's protocol ID
- DY-SH-1601
- Status last verified
- Jun 2017
- First submitted
- 25 May 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Multiple Center Study Observing the Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Coronary Artery Disease of Angina Pectoris
- ClinicalTrials.gov ID
- NCT03198091
- Acronym / sponsor ID
- DY-SH-1601
- Conditions
- Coronary Heart Disease
- Keywords
- stable angina pectoris, Dun Ye Guan Xin Ning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Wanbang Pharmaceutical Marketing Co.,Ltd.
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Jun 2017 (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.
This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.
Detailed description
A total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus Dun Ye Guan Xin Ning tablet for 6 months. Symptoms, questionnaires (SAQ, PSQI, and angina pectoris quantitative table of Chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, EKG, blood pressure and other physical examination will be collected at baseline and follow-up. Among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dun Ye Guan Xin Ning mono-therapy | Experimental | Drug: Dun Ye Guan Xin Ning |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 and 75 years.
- Documented stable angina pectoris.
- During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable.
- Patients with at least one of the following events: ① patients who have done PCI or CABG for more than half a year; ② coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. Symptom occurs at least once per month.
- Medications remain stable within 1 month before the enrollment.
Key exclusion criteria (13 listed)
- Patents with coronary heart disease acute coronary syndrome during the last 6 months.
- Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina.
- Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain.
- Patients combined with severe cardiopulmonary insufficiency (NYHA grade III ord IV), pulmonary insufficiency graded reference COPD clinical severity of lung function grade III (FEV1 / FVC <70%, 30% 1 / FVC% of predicted value <50%) and grade IV), severe arrhythmia (eg. III degree atrioventricular block)
- Patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (TBil ≥ 1.5ULN, AST ≥ 2ULN, ALT ≥ 2ULN, serum creatinine ≥ 1.5ULN, Hb <9mg/dL).
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 |
|---|---|---|
| Dun Ye Guan Xin NingDun Ye Guan Xin Ning tablet 320 mg orally every time and 3 times per day for 6 months. | Drug | Dun Ye Guan Xin Ning mono-therapy |
Primary outcome
Angina pectoris symptom
Time frame: 6 month
Improvement od angina pectoris symptom
4 secondary outcomes
Life quality
Time frame: 6 month
Sleep quality
Time frame: 6 month
Chest tightness
Time frame: 0, 1 month, 3 month, 6 month
Biomarkers
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dun Ye Guan Xin Ning in people with Coronary Heart Disease, run by Peking University First Hospital 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 7 inclusion and 13 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 23 Jun 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yong Huo, MD (8610-83572283, huoyong@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina pectoris symptom (time frame: 6 month). 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 23 Jun 2017.