Tanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients

February 26, 2026 updated by: Jinggang Xia, MD

A Clinical Study on Tanhuo Decoction in the Treatment of Acute Coronary Syndrome Combined With Cerebral Atherosclerosis in the Elderly

The goal of this clinical trial is to learn if Tanhuo decoction works to treat acute coronary syndrome combined with cerebral atherosclerosis in the elderly. It will also learn about the safety of Tanhuo decoction. The main questions it aims to answer are:

Can Tanhuo decoction reduce inflammatory markers in elderly patients with acute coronary syndrome combined with cerebral atherosclerosis and decrease the occurrence of adverse cardiovascular events? What medical problems do participants have when taking Tanhuo decoction? Researchers will compare Tanhuo decoction to a placebo (a look-alike substance that contains no drug) to see if Tanhuo decoction works to treat acute coronary syndrome combined with cerebral atherosclerosis in the elderly.

Participants will:Take Tanhuo decoction or a placebo every day for a week. undergo laboratory tests and echocardiography at baseline (before starting the medication), on day 7, and at 1 month after initiation, and will complete telephone follow-ups during hospitalization and at 1, 3, 6, and 12 months after discharge.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study adopts a prospective randomized controlled design. Patients with acute coronary syndrome combined with cerebral atherosclerosis who meet the inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either the Tanhuo Decoction group or the control group. The Tanhuo Decoction group will receive standard Western medical therapy plus Tanhuo Decoction, while the control group will receive standard Western medical therapy alone. A total of 480 patients are planned to be enrolled. The study will compare changes in white blood cell count and neutrophil count, as well as differences in high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) levels after 7 days of treatment and at 1 month after discharge. Differences in the Phlegm-Heat Syndrome Score and multi-omics detection results after 7 days of treatment will also be analyzed between the two groups. Changes in left ventricular end-diastolic diameter (LVEDD) and left ventricular ejection fraction (LVEF) at 1 month and 1 year after discharge will be evaluated. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 12 months after discharge will be compared between the two groups. MACCE is defined as the occurrence of any of the following events during the follow-up period: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization. This study aims to evaluate the effectiveness of Tanhuo Decoction in controlling inflammation-related indicators in elderly patients with acute coronary syndrome combined with cerebral atherosclerosis. Outcome measures and clinical endpoints include Phlegm-Heat Syndrome Score, inflammatory markers, cardiac function, and major adverse cardiovascular and cerebrovascular events

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100032
        • Xuanwu Hospital of Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Hemodynamic stability within 24 hours following treatment for acute coronary syndrome
  2. A confirmed prior diagnosis of ischemic cerebrovascular disease, or the presence of intracranial or extracranial arterial stenosis ≥50%, as verified by carotid and cerebrovascular ultrasound after admission
  3. Manifestations consistent with fire-heat syndrome, including tongue body appearance, tongue coating, stool characteristics, mental state, facial complexion, breathing pattern, presence of fever, pulse features, oral sensation, and urine properties. A total score of ≥7 points based on the weighted scoring system for each item indicates the presence of fire-heat syndrome.
  4. Age ≥ 60 years old

Exclusion Criteria:

  1. Patients with persistent hemodynamic instability beyond 24 hours, or those with ACS-related hypotension (SBP < 90 mmHg or DBP < 60 mmHg), or requiring coronary artery bypass grafting based on coronary artery lesions
  2. History of chronic heart failure due to any cause
  3. History of ischemic stroke, peptic ulcer, active bleeding, or major surgery within the past 3 months
  4. Hepatic or renal dysfunction, defined as ALT or AST levels >5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²
  5. Previous history of bronchial asthma
  6. Platelet count <80×10⁹/L or anemia (hemoglobin ≤100 g/L)
  7. Contraindication or allergy to aspirin, clopidogrel, ticagrelor, or statins
  8. History of malignant tumor
  9. Known allergy to components of traditional Chinese medicine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Participants will receive standard Western medicine combined with Tanhuo decoction for 7 days. Standard Western medicine is prescribed by the attending physician based on the patient's condition, referring to the guidelines for myocardial infarction. This includes medications such as antiplatelet drugs, statins, and beta-blockers, with no intervention from the researchers.
Drug: Tanhuo decoction
Participants will receive Tanhuo decoction for 7 days
Drug: standard Western medicine
Participants will receive standard Western medicine. Standard Western medicine is prescribed by the attending physician based on the patient's condition, referring to the guidelines for myocardial infarction. This includes medications such as antiplatelet drugs, statins, and beta-blockers, with no intervention from the researchers.
Placebo Comparator: control group
Participants will receive standard Western medicine. Standard Western medicine is prescribed by the attending physician based on the patient's condition, referring to the guidelines for myocardial infarction. This includes medications such as antiplatelet drugs, statins, and beta-blockers, with no intervention from the researchers.
Drug: standard Western medicine
Participants will receive standard Western medicine. Standard Western medicine is prescribed by the attending physician based on the patient's condition, referring to the guidelines for myocardial infarction. This includes medications such as antiplatelet drugs, statins, and beta-blockers, with no intervention from the researchers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of white blood cell (WBC) and neutrophil counts between 7 days of medication and 1 month post-discharge
Time Frame: Baseline, Day 7 of treatment, and 1 month post-discharge.
units are 10⁹/L
Baseline, Day 7 of treatment, and 1 month post-discharge.
Comparison of hsCRP levels between 7 days of medication and 1 month post-discharge
Time Frame: Baseline, Day 7 of treatment, and 1 month post-discharge.
units are mg/L
Baseline, Day 7 of treatment, and 1 month post-discharge.
Comparison of IL-6 levels at 7 days of medication and 1 month post-discharge.
Time Frame: Baseline, Day 7 of treatment, and 1 month post-discharge.
units are pg/mL
Baseline, Day 7 of treatment, and 1 month post-discharge.
Comparison of phlegm-heat syndrome scores between the two groups at day 7 post-treatment
Time Frame: Baseline and day 7 of treatment
The Phlegm-Heat Syndrome Score Scale was comprehensively assessed based on clinical manifestations, including tongue coating, halitosis (breath odor), facial complexion, pulse characteristics, bowel and urinary habits, and emotional status. The total score ranges from 0 to 31 points, with higher scores indicating greater severity of phlegm-heat syndrome. A total score of ≥ 7 points is considered diagnostic of phlegm-heat syndrome.
Baseline and day 7 of treatment
Number of Differentially Expressed Metabolites
Time Frame: Baseline and day 7 of treatment
Metabolomic analysis will be performed using liquid chromatography-mass spectrometry (LC-MS) to evaluate changes before and after Tanhuo Decoction treatment. The value reported will be the total count of metabolites showing statistically significant differences in concentration between baseline and day 7.
Baseline and day 7 of treatment
Number of Differentially Expressed Lipids
Time Frame: Baseline and Day 7 of treatment
Lipidomic analysis will be performed using liquid chromatography-mass spectrometry (LC-MS) to evaluate lipid profile changes before and after Tanhuo Decoction treatment. The value reported will be the total count of lipid species showing statistically significant differences between baseline and day 7.
Baseline and Day 7 of treatment
Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge
Time Frame: 1 month and 1 year post-discharge
1 month and 1 year post-discharge
Comparison of echocardiographic left ventricular ejection fraction at 1-month and 1-year post-discharge
Time Frame: 1 month and 1 year post-discharge
1 month and 1 year post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
major adverse cardiac and cerebrovascular events
Time Frame: 1, 3, and 6 months, and 1 year post-discharge
The incidence of MACCE, defined as the occurrence of any of the following events: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization during the follow-up period
1, 3, and 6 months, and 1 year post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinggang Xia, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZDYN-2024-A-006 (Other Grant/Funding Number: National Administration of Traditional Chinese Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy and confidentiality of study participants, individual participant data (IPD) will not be shared with external researchers in accordance with the informed consent obtained for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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