Coronary Heart DiseasePhase 4NCT02850627
The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
A Phase 4 study testing Tongguan capsule in people with Coronary Heart Disease and Acute Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Acute Myocardial Infarction
- What is being tested?
- Tongguan capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 4
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
- Postoperative routine drug treatment
- Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- Aged 35 to 75 years old
- Must sign a consent form.
Who cannot join
- Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- Serious cardiac insufficiency (EF < 35%)
- Uncontrolled patients with high blood pressure
- Merger or severe valvular heart disease in acute cerebrovascular disease
- Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
Show all 12Show fewer
- Patients with severe mental illness
- Patients with malignant tumor or life expectancy in less than three years
- Patients with severe hematopoietic system disease
- Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
- Pregnancy or ready to pregnant women, nursing mothers;
- Participated in nearly three months, or is in other clinical subjects . -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Minzhou Zhang, MD, 86-20-81887233 ext. 32808, 1542377671@qq.com
Huizheng Zhu, PhD
About this study
Official title: The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
Read the detailed description
The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months
- Being tested
- Tongguan capsule, placebo capsule
- Keywords
- acute coronary syndrome, Tongguan capsule, miRNAs
- Medical subject headings
- Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongguan capsuleDrug
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
placebo capsuleDrug
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
| Study group | Role | What they receive |
|---|---|---|
| Tongguan capsule | Experimental | Tongguan capsule (0.5 g tid. for 6 months) Receives: Drug: Tongguan capsule |
| placebo capsule | Placebo comparator | same volume/day of placebo capsule (0.5 g tid. for 6 months) Receives: Drug: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNAs spectrum
Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
Measured: six months
Secondary outcomes (12)
major adverse cardiac event
frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)
Measured: six months
Renin predicts cardiovascular homeostasis and ventricular remodeling
renin（ng/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
Measured: 6 months
Ang II predicts cardiovascular homeostasis and ventricular remodeling
Ang II（pg/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
Measured: 6 months
Serum E
Acute coronary syndrome is caused by atherosclerotic plaque instability and rupture. The stability of plaque is closely related to inflammation.Serum E (pmol / L) is an important pathway of various immune and inflammatory regulation, which promotes the development of atherosclerosis and is a risk factor for atherosclerosis.
Measured: 6 months
Inflammatory mediators
Tumor Necrosis factor alpha (ng/L)and Interleukin-6，IL-6 (ng/L) measure of the general situation of patients
Measured: 6 months
Brain Natriuretic Peptide
B-type natriuretic peptide（pg/ml） is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation
Measured: 6 months
Echocardiography measure of left ventricular systolic function
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
Measured: 6 months
Echocardiography measure of left ventricular diastolic function
Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients
Measured: 6 months
New York Heart Association functional classification
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: 6 months
Coronary angiography
Quantitative coronary angiography in the stenosis degree, 25%, 50%, 75%, 90%, 99%, 100%, 1, 2, 4, 6, 8,, 16, 32, and, respectively.
Scoring multiplication will segment coefficients corresponding to the degree of stenosis and the stenosis of total score that is the sum of Gensini score of coronary artery stenosis in the patients.
Measured: 6 months
Seattle Angina Questionnaire score
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).
Measured: 6 months
The traditional Chinese medicine syndrome scale
The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with traditional Chinese medicine syndrome type
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Minzhou Zhang, MD, Study director, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese MedicineHuizheng Zhu, PhD, Principal investigator, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850627
- Sponsor's protocol ID
- B2015-129-01
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02850627
- Acronym / sponsor ID
- B2015-129-01
- Keywords
- acute coronary syndrome, Tongguan capsule, miRNAs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Aug 2016 (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.
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
Detailed description
The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongguan capsule | Experimental | Drug: Tongguan capsuleTongguan capsule (0.5 g tid. for 6 months) |
| placebo capsule | Placebo comparator | Drug: placebo capsulesame volume/day of placebo capsule (0.5 g tid. for 6 months) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
- Postoperative routine drug treatment
- Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- Aged 35 to 75 years old
- Must sign a consent form.
Key exclusion criteria (12 listed)
- Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- Serious cardiac insufficiency (EF < 35%)
- Uncontrolled patients with high blood pressure
- Merger or severe valvular heart disease in acute cerebrovascular disease
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 |
|---|---|---|
| Tongguan capsuleeligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI) | Drug | Tongguan capsule |
| placebo capsuleeligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI) | Drug | placebo capsule |
Primary outcome
miRNAs spectrum
Time frame: six months
Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
12 secondary outcomes
major adverse cardiac event
Time frame: six months
Renin predicts cardiovascular homeostasis and ventricular remodeling
Time frame: 6 months
Ang II predicts cardiovascular homeostasis and ventricular remodeling
Time frame: 6 months
Serum E
Time frame: 6 months
Inflammatory mediators
Time frame: 6 months
Brain Natriuretic Peptide
Time frame: 6 months
Echocardiography measure of left ventricular systolic function
Time frame: 6 months
Echocardiography measure of left ventricular diastolic function
Time frame: 6 months
New York Heart Association functional classification
Time frame: 6 months
Coronary angiography
Time frame: 6 months
Seattle Angina Questionnaire score
Time frame: 6 months
The traditional Chinese medicine syndrome scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Minzhou Zhang, MD study director
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
Huizheng Zhu, PhD principal investigator
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongguan capsule in people with Coronary Heart Disease and Acute Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional 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 5 inclusion and 12 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 2 Aug 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Huizheng Zhu, PHD (86-20-81887233 ext. 32808, 754357604@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNAs spectrum (time frame: six 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 2 Aug 2016.