Acute Coronary Syndrome Comorbid With Cerebral AtherosclerosisNCT07445581
Tanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients
A study testing Tanhuo decoction and standard Western medicine in people with Acute Coronary Syndrome Comorbid With Cerebral Atherosclerosis, run by Jinggang Xia, MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Coronary Syndrome Comorbid With Cerebral Atherosclerosis
- What is being tested?
- Tanhuo decoction and standard Western medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamic stability within 24 hours following treatment for acute coronary syndrome
- 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
- 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.
- Age ≥ 60 years old
Who cannot join
- 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
- History of chronic heart failure due to any cause
- History of ischemic stroke, peptic ulcer, active bleeding, or major surgery within the past 3 months
- 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
- Previous history of bronchial asthma
- Platelet count <80×10⁹/L or anemia (hemoglobin ≤100 g/L)
Show all 9Show fewer
- Contraindication or allergy to aspirin, clopidogrel, ticagrelor, or statins
- History of malignant tumor
- Known allergy to components of traditional Chinese medicine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100032
Jinggang Xia, 86+13621041267, xiajinggang@sina.cn
About this study
Official title: 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.
Read the 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
- Being tested
- Tanhuo decoction, standard Western medicine
- Keywords
- acute coronary syndrome, cerebral atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tanhuo decoctionDrug
Participants will receive Tanhuo decoction for 7 days
standard Western medicineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Drug: Tanhuo decoction; Drug: standard Western medicine |
| control group | Placebo comparator | 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. Receives: Drug: standard Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of white blood cell (WBC) and neutrophil counts between 7 days of medication and 1 month post-discharge
units are 10⁹/L
Measured: Baseline, Day 7 of treatment, and 1 month post-discharge.
Comparison of hsCRP levels between 7 days of medication and 1 month post-discharge
units are mg/L
Measured: 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.
units are pg/mL
Measured: 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
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.
Measured: Baseline and day 7 of treatment
Number of Differentially Expressed Metabolites
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.
Measured: Baseline and day 7 of treatment
Number of Differentially Expressed Lipids
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.
Measured: Baseline and Day 7 of treatment
Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge
Measured: 1 month and 1 year post-discharge
Comparison of echocardiographic left ventricular ejection fraction at 1-month and 1-year post-discharge
Measured: 1 month and 1 year post-discharge
Secondary outcomes (1)
major adverse cardiac and cerebrovascular events
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
Measured: 1, 3, and 6 months, and 1 year post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome Comorbid With Cerebral AtherosclerosisStudies 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
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinggang Xia, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinggang Xia, MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445581
- Sponsor's protocol ID
- ZDYN-2024-A-006
- Other IDs
- ZDYN-2024-A-006
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Tanhuo Decoction in the Treatment of Acute Coronary Syndrome Combined With Cerebral Atherosclerosis in the Elderly
- ClinicalTrials.gov ID
- NCT07445581
- Acronym / sponsor ID
- ZDYN-2024-A-006
- Keywords
- acute coronary syndrome, cerebral atherosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jinggang Xia, MDUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Tanhuo decoction, Drug: standard Western medicineParticipants 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. |
| control group | Placebo comparator | Drug: standard Western medicineParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hemodynamic stability within 24 hours following treatment for acute coronary syndrome
- 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
- 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.
- Age ≥ 60 years old
Key exclusion criteria (9 listed)
- 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
- History of chronic heart failure due to any cause
- History of ischemic stroke, peptic ulcer, active bleeding, or major surgery within the past 3 months
- 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
- Previous history of bronchial asthma
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 |
|---|---|---|
| Tanhuo decoctionParticipants will receive Tanhuo decoction for 7 days | Drug | Treatment group |
| standard Western medicineParticipants 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 | Treatment group, control group |
Primary outcome
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
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
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
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.
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.
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.
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
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 secondary outcome
major adverse cardiac and cerebrovascular events
Time frame: 1, 3, and 6 months, and 1 year post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. 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
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tanhuo decoction and standard Western medicine in people with Acute Coronary Syndrome Comorbid With Cerebral Atherosclerosis, run by Jinggang Xia, MD 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 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinggang Xia (86+13621041267, xiajinggang@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 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 3 Mar 2026.