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 range60 Years

SexALL

See this in plain English?

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

✕. 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

What they're measuring

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.

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.

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.

Comparison of phlegm-heat syndrome scores between the two groups at day 7 post-treatment

Timeframe: Baseline and day 7 of treatment

Number of Differentially Expressed Metabolites

Timeframe: Baseline and day 7 of treatment

Number of Differentially Expressed Lipids

Timeframe: Baseline and Day 7 of treatment

Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge

Timeframe: 1 month and 1 year post-discharge

Trial details

NCT IDNCT07445581

SponsorJinggang Xia, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Jinggang Xia

86+13621041267 xiajinggang@sina.cn

View on ClinicalTrials.gov More Acute Coronary Syndrome Comorbid With Cerebral Atherosclerosis trials

Plain-language summary

Who can participate

Age range60 Years

SexALL

See this in plain English?

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

✕. 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

What they're measuring

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.

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.

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.

Comparison of phlegm-heat syndrome scores between the two groups at day 7 post-treatment

Timeframe: Baseline and day 7 of treatment

Number of Differentially Expressed Metabolites

Timeframe: Baseline and day 7 of treatment

Number of Differentially Expressed Lipids

Timeframe: Baseline and Day 7 of treatment

Comparison of echocardiographic left ventricular end-diastolic diameter at 1-month and 1-year post-discharge

Timeframe: 1 month and 1 year post-discharge