Tanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients (NCT07445581) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients
China480 participantsStarted 2026-02-28
Plain-language 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. 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.
Who can participate
Age range
60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of white blood cell (WBC) and neutrophil counts between 7 days of medication and 1 month post-discharge
Timeframe: Baseline, Day 7 of treatment, and 1 month post-discharge.
2
Comparison of hsCRP levels between 7 days of medication and 1 month post-discharge
Timeframe: Baseline, Day 7 of treatment, and 1 month post-discharge.
3
Comparison of IL-6 levels at 7 days of medication and 1 month post-discharge.
Timeframe: Baseline, Day 7 of treatment, and 1 month post-discharge.
4
Comparison of phlegm-heat syndrome scores between the two groups at day 7 post-treatment
Timeframe: Baseline and day 7 of treatment
5
Number of Differentially Expressed Metabolites
Timeframe: Baseline and day 7 of treatment
6
Number of Differentially Expressed Lipids
Timeframe: Baseline and Day 7 of treatment
7
Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge
. 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
Timeframe: 1 month and 1 year post-discharge
8
Comparison of echocardiographic left ventricular ejection fraction at 1-month and 1-year post-discharge