Angina PectorisNCT01715376
Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events
An observational study of Angina Pectoris and Coronary Artery Disease, run by Changchun University of Chinese Medicine at 1 site in China.
Trial summary
Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Angina Pectoris, Coronary Artery Disease, Coronary Disease
- How many people
- 1,042 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jun 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: treat with combination of standardized western medical drug therapy and Chinese medical continued treatment
Who may be able to join
- the patients who are according with the II、III stage in CHD western medical diagnosis standard；
- age between 18 and 75(including 18 and 75)；
- Signed the informed consent voluntarily.
Who cannot join
- The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
- the patients who have myocardial infarction or vascular remodeling in last 3 months；
- hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；
- the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）；
- the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
- any other sever diseases such as malignant tumor；
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- the patients who attending other clinical study in late 3 months；
- pregnant or lactating women；
- the patients who have allergic constitution or are allergic to many drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Jilin Province TCM Institute of Chinese Medicine
Changchun, Jilin, 130000
About this study
Official title: Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.
Read the detailed description
We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
- Conditions
- Angina Pectoris, Coronary Artery Disease, Coronary Disease, Heart Disease, Cardiovascular Disease, Chest Pain
- Keywords
- traditional chinese medicine, complementary therapies, traditional chinese medicine syndrome scale
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Chest Pain, Pain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Chinese and western medicine | Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study. | |
| Western medicine | western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point all cause death
all because of death, stroke, nonfatal myocardial infarction, revascularization.
Measured: up to 12 months
Secondary endpoint hospitalization
the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
Measured: up to 12months
Secondary outcomes (2)
Angina symptoms
Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.
Measured: up to 12months
electrocardiogram
Measured: up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yue deng, Changchun University of Chinese Medicine
- Investigators
- deng yue, Study chair, dirctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715376
- Sponsor's protocol ID
- 201007001-3-1
- Status last verified
- May 2020
- First submitted
- 14 Sep 2012
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
- ClinicalTrials.gov ID
- NCT01715376
- Acronym / sponsor ID
- 201007001-3-1
- Conditions
- Angina Pectoris, Coronary Artery Disease, Coronary Disease, Heart Disease, Cardiovascular Disease, Chest Pain
- Keywords
- traditional chinese medicine, complementary therapies, traditional chinese medicine syndrome scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Changchun University of Chinese MedicineUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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 standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.
Detailed description
We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Chinese and western medicine | – | –Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study. |
| Western medicine | – | –western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- treat with combination of standardized western medical drug therapy and Chinese medical continued treatment
Key inclusion criteria (3 listed)
- the patients who are according with the II、III stage in CHD western medical diagnosis standard；
- age between 18 and 75(including 18 and 75)；
- Signed the informed consent voluntarily.
Key exclusion criteria (9 listed)
- The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
- the patients who have myocardial infarction or vascular remodeling in last 3 months；
- hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；
- the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）；
- the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary end point all cause death
Time frame: up to 12 months
all because of death, stroke, nonfatal myocardial infarction, revascularization.
Secondary endpoint hospitalization
Time frame: up to 12months
the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
2 secondary outcomes
Angina symptoms
Time frame: up to 12months
electrocardiogram
Time frame: up to 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
deng yue study chair
dirctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Coronary Artery Disease, run by 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: finished, as of the sponsor's last update on 27 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point all cause death (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.