Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide (TCM-TMAO)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Acute Coronary Syndrome

Treatments: Drug: Compound Panax Notoginseng Granule; Drug: Placebo Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03186625

YN2015MS21

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
2. TCM syndrome: Intermingled Phlegm and Blood Stasis.
3. Aged 18 to 80 years old.
4. sign a consent form.

Exclusion criteria

1. Cardiogenic shock.
2. Serious heart failure (NYHA IV or LVEF < 40%).
3. With severe valvular heart disease.
4. 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.
5. With acute cerebrovascular disease or severe mental illness.
6. With active bleeding or severe hematopoietic system disease.
7. With malignant tumor or life expectancy in less than three years.
8. Pregnancy or ready to pregnant women, nursing mothers.
9. History of taking antibiotics within the past two months.
10. Participating in other clinical subjects .
11. Failure to sign a consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Compound Panax Notoginseng Granule

Experimental group

Description:

On the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll.

Treatment:

Drug: Compound Panax Notoginseng Granule

Placebo Granule

Placebo Comparator group

Description:

On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.

Treatment:

Drug: Placebo Granule