Acute Coronary SyndromeTCM-TMAONCT03186625
Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide
A study testing Compound Panax Notoginseng Granule in people with Acute Coronary Syndrome, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Compound Panax Notoginseng Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2017to 31 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
- TCM syndrome: Intermingled Phlegm and Blood Stasis.
- Aged 18 to 80 years old.
- sign a consent form.
Who cannot join
- Cardiogenic shock.
- Serious heart failure (NYHA IV or LVEF < 40%).
- With severe valvular heart disease.
- Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
- With acute cerebrovascular disease or severe mental illness.
- With active bleeding or severe hematopoietic system disease.
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- With malignant tumor or life expectancy in less than three years.
- Pregnancy or ready to pregnant women, nursing mothers.
- History of taking antibiotics within the past two months.
- Participating in other clinical subjects .
- Failure to sign a consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Lei Wang, M.D, 8620-81887233-32801, Dr.wanglei@139.com
About this study
Official title: Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota. Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention. 80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG). The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period. All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Compound Panax Notoginseng Granule, Placebo Granule
- Keywords
- acute coronary syndrome, gut microbiota, Trimethylamine N-oxide, percutaneous coronary intervention
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Panax Notoginseng GranuleDrug
Dosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc.
Frequency:two times a day, one package per time. Duration:three months.
Placebo GranuleDrug
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
| Study group | Role | What they receive |
|---|---|---|
| Compound Panax Notoginseng Granule | Experimental | On the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll. Receives: Drug: Compound Panax Notoginseng Granule |
| Placebo Granule | Placebo comparator | On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll. Receives: Drug: Placebo Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the plasma level of TMAO
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
Measured: baseline
the plasma level of TMAO
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
Measured: 90-days post-procedure
Secondary outcomes (12)
metagenomic DNA sequencing analysis of faecal microbiome
high-throughput sequencing and big data analytics
Measured: baseline
metagenomic DNA sequencing analysis of faecal microbiome
high-throughput sequencing and big data analytics
Measured: 90-days post-procedure
major adverse cardiac event
frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )
Measured: 90-days post-procedure
cardiac function
left ventricular ejection fraction(LVEF) evaluated by echo
Measured: baseline
cardiac function
left ventricular ejection fraction(LVEF) evaluated by echo
Measured: 90-day at follow-up
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).
Measured: 90-days
The traditional Chinese medicine syndrome scale
The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.
Measured: change from baseline at 90-days
lipid metabolism
low-density lipoprote in cholesterol in mmol/L
Measured: change from baseline at 90-days
lipid metabolism
total cholesterol in cholesterol in mmol/L
Measured: change from baseline at 90-days
inflammatory factors
C-reactive protein in mg/L
Measured: change from baseline at 90-days
platelet function
maximal aggregation rate of platelet in percent
Measured: change from Baseline at 90-days
cardiac biomarkers of necrosis
cardiac troponin T (cTnT) in ug/L
Measured: Change from Baseline at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start5 Dec 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Genomics Institute
- Responsible party
- Principal investigator, Lei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Xiaoyan Li, Master, Study director, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186625
- Sponsor's protocol ID
- YN2015MS21
- Acronym
- TCM-TMAO
- Status last verified
- Dec 2017
- First submitted
- 7 Jun 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03186625
- Acronym / sponsor ID
- TCM-TMAO / YN2015MS21
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, gut microbiota, Trimethylamine N-oxide, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing Genomics Institute
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 14 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.
Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota. Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention. 80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG). The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period. All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compound Panax Notoginseng Granule | Experimental | Drug: Compound Panax Notoginseng GranuleOn the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll. |
| Placebo Granule | Placebo comparator | Drug: Placebo GranuleOn the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
- TCM syndrome: Intermingled Phlegm and Blood Stasis.
- Aged 18 to 80 years old.
- sign a consent form.
Key exclusion criteria (11 listed)
- Cardiogenic shock.
- Serious heart failure (NYHA IV or LVEF < 40%).
- With severe valvular heart disease.
- Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
- With acute cerebrovascular disease or severe mental illness.
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 |
|---|---|---|
| Compound Panax Notoginseng GranuleDosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc. Frequency:two times a day, one package per time. Duration:three months. | Drug | Compound Panax Notoginseng Granule |
| Placebo GranulePlacebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration. | Drug | Placebo Granule |
Primary outcome
the plasma level of TMAO
Time frame: baseline
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
the plasma level of TMAO
Time frame: 90-days post-procedure
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
12 secondary outcomes
metagenomic DNA sequencing analysis of faecal microbiome
Time frame: baseline
metagenomic DNA sequencing analysis of faecal microbiome
Time frame: 90-days post-procedure
major adverse cardiac event
Time frame: 90-days post-procedure
cardiac function
Time frame: baseline
cardiac function
Time frame: 90-day at follow-up
Seattle Angina Questionnaire score
Time frame: 90-days
The traditional Chinese medicine syndrome scale
Time frame: change from baseline at 90-days
lipid metabolism
Time frame: change from baseline at 90-days
lipid metabolism
Time frame: change from baseline at 90-days
inflammatory factors
Time frame: change from baseline at 90-days
platelet function
Time frame: change from Baseline at 90-days
cardiac biomarkers of necrosis
Time frame: Change from Baseline at 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
Xiaoyan Li, Master study director
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound Panax Notoginseng Granule in people with Acute Coronary Syndrome, 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 4 inclusion and 11 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 7 Dec 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. 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.
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 Lei Wang, Ph.D & M.D (86-20-81887233-32801, Dr.wanglei@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the plasma level of TMAO (time frame: baseline). 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 7 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.