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| ID | Type | Description | Link |
|---|---|---|---|
| ZDYN-2024-A-006 | Other Grant/Funding Number | National Administration of Traditional Chinese Medicine |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanhuo decoction | Drug | Participants will receive Tanhuo decoction for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of white blood cell (WBC) and neutrophil counts between 7 days of medication 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 | 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. | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1, 3, and 6 months, and 1 year post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinggang Xia | Contact | 86+13621041267 | xiajinggang@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital of Capital Medical University | Beijing | Beijing Municipality | 100032 | China |
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2025 | Feb 18, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2025 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| standard Western medicine |
| Drug |
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. |
|
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 | 1 month and 1 year post-discharge |
| Comparison of echocardiographic left ventricular ejection fraction at 1-month and 1-year post-discharge | 1 month and 1 year post-discharge |
| D020765 |
| Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |