A Clinical Study on Tanhuo Decoction in the Treatment of Acute Coronary Syndrome Combined With Cerebral Atherosclerosis in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Contraindication or allergy to aspirin, clopidogrel, ticagrelor, or statins
- •History of malignant tumor
- •Known allergy to components of traditional Chinese medicine
研究组 & 干预措施
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.
干预措施: Tanhuo decoction (Drug)
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.
干预措施: standard Western medicine (Drug)
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.
干预措施: standard Western medicine (Drug)
结局指标
主要结局
Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge
时间窗: 1 month and 1 year post-discharge
Comparison of echocardiographic left ventricular ejection fraction at 1-month and 1-year post-discharge
时间窗: 1 month and 1 year post-discharge
Comparison of white blood cell (WBC) and neutrophil counts between 7 days of medication and 1 month post-discharge
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- major adverse cardiac and cerebrovascular events(1, 3, and 6 months, and 1 year post-discharge)
研究者
Jinggang Xia, MD
Principal Investigator
Xuanwu Hospital, Beijing