A Clinical Study on Tanhuo Decoction in the Treatment of Acute Coronary Syndrome Combined With Cerebral Atherosclerosis in the Elderly
Phase: NA
Conditions: Acute Coronary Syndrome Comorbid With Cerebral Atherosclerosis
Sponsor: Jinggang Xia, MD

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A Clinical Study on Tanhuo Decoction in
the Treatment of Acute Coronary
Syndrome Combined With Cerebral
Atherosclerosis in the Elderly
Principal Investigator (at this institution): Xia Jinggang
Department: Cardiology (Internal Medicine)
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Contact Person: Xia Jinggang
Contact Phone: +86 136 2104 1264

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Research Summary
This project aims to evaluate the efficacy of Tanhuo Decoction in treating
comorbid inflammation in elderly patients with Acute Coronary Syndrome (ACS) and
cerebral arteriosclerosis. Adopting a multicenter, prospective, randomized controlled
research methodology, the study targets patients aged 60 and older with ACS and
concomitant cerebral atherosclerosis. Of the total sample size of 480 cases, our center
will undertake 400, which will be randomly assigned to either the Tanhuo Decoction
treatment group or the control group. The study will analyze and compare the two
groups in terms of phlegm-heat syndrome scores, inflammatory biomarkers, cardiac
function, and the incidence of Major Adverse Cardiac and Cerebrovascular Events
(MACCE) during hospitalization and within a one-year post-discharge follow-up
period.

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Main text
1.Background and Rationale
As China enters an aging society, the coexistence of elderly Coronary Artery
Disease (CAD) and cerebrovascular atherosclerotic disease has become increasingly
prevalent. These conditions represent different clinical manifestations of a shared
underlying pathology—atherosclerosis—within two vital organ systems, which
interact and exacerbate one another. Despite receiving standard Western medical
interventions,
including
pharmacotherapy,
interventional
therapy,
carotid
endarterectomy, and coronary artery bypass grafting (CABG), patients with comorbid
coronary and cerebrovascular diseases continue to face poor prognoses.
As early as the 1960s, Professor Zhao Buchang began researching Traditional
Chinese Medicine (TCM) therapies for cardio-cerebrovascular diseases.
This
approach is rooted in the TCM theories of "treating different diseases with the same
method," "common origin of brain and heart," and "brain-heart co-pathology," based
on the physiological and pathological connections between the brain and heart. In
1993, Professor Zhao Buchang, along with Professor Wu Haiqin and Dr. Zhao Tao,
innovatively proposed the theory of "Simultaneous Treatment of Brain and Heart" .
This
theory
interprets
the
pathogenesis
and
therapeutic
principles
of
cardio-cerebrovascular diseases from a holistic perspective, guiding clinical practice
with significant efficacy. Subsequent extensive clinical, experimental, and literature
research has
validated "Simultaneous
Treatment
of Brain and
Heart"
as a
scientifically rigorous and innovative theoretical framework.
Cardio-cerebrovascular
atherosclerosis
is
a
chronic
inflammatory
disease
centered on lipid accumulation. Inflammation remains a critical residual risk even
after lipid levels are effectively controlled, and its predictive value for cardiovascular
events exceeds that of residual cholesterol risk [1]. Our team’s recent studies have
shown
that
inflammatory
mechanisms
contribute
to
atherosclerotic
plaque
vulnerability [2] and disease severity [3]. While Glucagon-like peptide-1 (GLP-1)

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receptor
agonists
reduce
atherosclerosis
through
anti-inflammatory
effects
independent of glucose lowering [4], and glutamine intervention exerts protective
effects by inhibiting inflammatory signaling pathways [5], landmark clinical trials
such as CANTOS [6], COLCOT [7], and LoDoCo2 [8] have provided high-level
evidence-based support for the clinical application of anti-inflammatory therapies.
However, Western pharmacological interventions for inflammatory pathways face
challenges such as single-target limitations, high costs, or significant adverse effects.
For instance, IL-1β monoclonal antibodies failed to achieve widespread clinical use
due to an increased risk of fatal infections [9]. Currently, only low-dose colchicine
(0.5mg/d) is recommended for the secondary prevention of coronary heart disease in
the 2023 ESC Guidelines for the Management of Acute Coronary Syndromes [10].
Due to their advantages in systemic regulation and multi-target modulation of
signaling pathways, TCM formulas have recently been found to play a crucial role in
reducing inflammatory responses and improving prognosis in CAD [11, 12]. Tanhuo
Decoction is an empirical prescription developed by Professor Gao Li and his team at
Xuanwu Hospital, Capital Medical University, based on years of clinical practice.
Research has confirmed its multi-faceted neuroprotective effects in patients with
ischemic stroke [13, 14], and small-sample studies on Tanhuo Decoction intervention
in acute myocardial infarction have also demonstrated its cardio-renal protective
effects [15]. Based on these preliminary findings, this project aims to establish a
research platform and team dedicated to cardio-cerebrovascular atherosclerotic
comorbidities in the elderly to verify the efficacy of Tanhuo Decoction in controlling
inflammation and improving patient prognosis. Therefore, the implementation of this
project is of great clinical significance.
2. Research Objectives
The objective of this study is to evaluate the efficacy of Tanhuo Decoction in
managing inflammatory biomarkers among elderly patients with comorbid Acute
Coronary Syndrome (ACS) and cerebral atherosclerosis. The specific observational

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indices and clinical outcomes include Phlegm-Heat syndrome scores, inflammatory
markers, cardiac function, and the incidence of Major Adverse Cardiac and
Cerebrovascular Events (MACCE)
3. Research Methods and Design
3.1 Study Design
Using a prospective randomized controlled research methodology, patients
meeting
the
inclusion
and
exclusion
criteria
with
ACS
and
concomitant
cerebrovascular atherosclerosis will be randomly assigned to either the Tanhuo
Decoction treatment group or the control group. The study will analyze and compare
the efficacy of Tanhuo Decoction in controlling inflammatory responses.
3.2 Study Population
The study population consists of patients with Acute Coronary Syndrome (ACS)
and concomitant cerebral atherosclerosis. ACS includes acute myocardial infarction
(AMI) and unstable angina (UA). The diagnostic criteria for AMI include persistent
chest pain, ST-segment elevation or depression on electrocardiogram (ECG), and
significant elevation of cardiac enzymes (such as troponin), following the exclusion of
other etiologies. The diagnostic criteria for UA include chest pain and ST-segment
elevation or depression on ECG, with negative cardiac enzymes (such as troponin),
following the exclusion of other etiologies. Cerebral atherosclerosis is diagnosed
based on carotid intima-media thickening (IMT ≥1.0 mm).
The study population will be recruited from cardiology departments across
multiple centers, including Xuanwu Hospital of Capital Medical University, Beijing
Friendship Hospital of Capital Medical University, Peking University First Hospital,
Beijing Huimin Hospital, Beijing Electric Power Hospital, Guang'anmen Hospital of
China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of
Chinese Medical Sciences, and Dongfang Hospital of Beijing University of Chinese
Medicine, from September 2025 to December 2028.
3.3 Selection Criteria
Inclusion Criteria: (1) Hemodynamic stability achieved within 24 hours of

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treatment for Acute Coronary Syndrome; (2) A confirmed diagnosis of previous
ischemic cerebrovascular disease, or intracranial or extracranial arterial stenosis 50%
or greater confirmed by carotid and cerebral ultrasound after admission; (3) Presence
of Phlegm-Heat syndrome: assessment includes tongue body, tongue coating, bowel
movements, mental state, facial expression, respiration, fever, pulse, oral sensation,
and urine, with a total weighted score of 7 or higher; (4) Age 60 years or older; (5)
Male or female; (6) Signed informed consent.
Exclusion Criteria: (1) Hemodynamic instability persisting beyond 24 hours,
ACS-related hypotension (blood pressure below 90/60 mmHg), or patients requiring
coronary artery bypass grafting (CABG) based on coronary anatomy; (2) Pre-existing
chronic heart failure of any etiology; (3) History of ischemic stroke, peptic ulcer,
active bleeding, or major surgery within the past 3 months; (4) Hepatic or renal
insufficiency: ALT or AST greater than 5 times the upper limit of normal, or
creatinine clearance less than 30 mL/min/1.73m2; (5) History of bronchial asthma; (6)
Platelet count less than 80x10^9/L or anemia (hemoglobin 100 g/L or less); (7)
Contraindication or allergy to aspirin, clopidogrel, ticagrelor, or statins; (8) History of
neoplastic diseases; (9) Known allergy to components of the Traditional Chinese
Medicine decoction.
Withdrawal Criteria: (1) Participant withdraws informed consent or is lost to
follow-up; (2) Changes or progression in clinical condition where the investigator
determines that continued participation poses an increased risk; (3) Pregnancy in
female participants; (4) Serious or intolerable adverse events that preclude continued
participation; (5) Concurrent participation in other clinical trials during the study
period; (6) Poor compliance, where the investigator determines the participant is
unsuitable to continue after a comprehensive evaluation.
3.4 Intervention and Control Group Design
Patients with elderly
acute coronary
syndrome combined
with cerebral
atherosclerosis who meet the inclusion and exclusion criteria will be randomly
assigned to either the Tanhuo Decoction treatment group or the control group in a 1:1
ratio. The control group will receive a placebo.

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Treatment
Group:
Tanhuo
Decoction,
one
bag
per
dose,
twice
daily,
administered orally for a total of 7 days.
3.5 Investigational Products
Tanhuo Decoction is currently an in-hospital Traditional Chinese Medicine
(TCM) preparation of Xuanwu Hospital, Capital Medical University. Its composition
includes: Forsythiae Fructus (Lianqiao) 10g, Coptidis Rhizoma (Huanglian) 9g,
Lophatheri Herba (Danzhuye) 9g, Arisaema cum Bile (Dannanxing) 9g, and Rhei
Radix et Rhizoma (Dahuang) 5g. The dosage is one dose per day. The hospital's
Pharmacy
Department
prepares
the
decoction
through
water
decocting
and
concentration to obtain 200 mL of decoction, which is then packaged in bags and
delivered to the wards. It is stored in a refrigerator at 4°C, and 100 mL is administered
warm twice daily (morning and evening) via oral intake or nasal feeding. Years of
clinical application have demonstrated that Tanhuo Decoction has an excellent safety
profile, with no adverse reactions reported to date. This multi-center study uses
Tanhuo Decoction exclusively supplied by the Department of Pharmacy of Xuanwu
Hospital, Capital Medical University.
3.6 Concomitant Medications and Precautions
Tanhuo Decoction should be administered at least 30 minutes apart from other
medications. There are no known drug-drug contraindications (incompatibility).
3.7 Randomization Design
In this study, a random number table will be generated using SAS 9.4 software,
and patients will be assigned to two groups based on the randomization results.
3.8 Selection and Validation of Primary Outcome Measures
Primary Endpoints: The primary evaluation includes comparing changes in white
blood cell (WBC) count, neutrophil count, high-sensitivity C-reactive protein
(hs-CRP), and interleukin-6 (IL-6) levels between 7 days of treatment and 1 month
post-discharge. Additionally, differences in Phlegm-Heat syndrome scores and
multi-omics results will be assessed between the two groups after 7 days of treatment,
alongside changes in left ventricular end-diastolic diameter (LVEDD) and left
ventricular ejection fraction (LVEF) at 1 month and 1 year post-discharge. Secondary

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Endpoints: The secondary evaluation focuses on the 12-month incidence of major
adverse cardiac and cerebrovascular events (MACCE) following discharge, including
cardiovascular
death,
non-fatal
myocardial
infarction,
stent
thrombosis,
ischemia-driven revascularization, stable or unstable angina, heart failure, transient
ischemic attack (TIA), and cerebral infarction. Safety Endpoints: Safety will be
monitored based on the incidence of all adverse events (AEs) during the
administration of Tanhuo Decoction and the incidence of serious adverse events
(SAEs)
3.9 Follow-up Plan
All patients will undergo follow-up at 1 month, 3 months, 6 months, and 12
months after discharge.
4. Preliminary Research Foundation
As an in-hospital preparation, Tanhuo Decoction has become a synergistic
formula for acute cerebral infarction, supported by numerous published original
articles and authorized patents. It has been confirmed that Tanhuo Decoction
significantly improves the prognosis and cerebral perfusion of patients with acute
cerebral infarction (Phlegm-Heat syndrome), while reducing serum inflammatory
factor levels, inhibiting inflammatory responses, and regulating gut microbiota.
Furthermore, network pharmacology research indicates that Coptidis Rhizoma
(Huanglian), Rhei Radix et Rhizoma (Dahuang), and Lophatheri Herba (Danzhuye)
exert anti-inflammatory and antioxidant effects through multiple signaling pathways.
5.Research Site and Data Management
After sample collection, specimens will be sent to the Department of Clinical
Laboratory of our hospital. A standardized Case Report Form (CRF) and database
will be established. Strict supervision will be implemented throughout the processes
of data reception and entry, data verification, data auditing, database locking, data
export and transmission, as well as the archiving of data and data management
documents.
6. Statistical Analysis Plan
6.1 Sample Size Calculation

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Sample Size Calculation for Patients with Acute Coronary Syndrome and
Coexisting Cerebrovascular Atherosclerosis in the Department of Cardiology:This
study is a prospective, randomized controlled trial employing a 1:1 parallel-group
design.
The
changes
in
white
blood
cell
(WBC)
count,
neutrophil
count,
high-sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6) levels were
selected as the primary endpoints. With a significance level (α) set at 0.05 (two-tailed)
and a statistical power (1-β) of 85%, the required sample sizes per group for each
indicator were calculated as follows: 119 cases for WBC and neutrophil counts, 86
cases for IL-6, and 191 cases for hs-CRP. Accounting for a 20% dropout rate, the
adjusted sample sizes for each indicator are: 149 cases for WBC and neutrophil
counts, 108 cases for IL-6, and 239 cases for hs-CRP. Based on these calculations and
a conservative estimate using the maximum sample size required for hs-CRP, each
group should enroll 239 cases, resulting in a total required sample size of 478.
Considering clinical feasibility, this study finally intends to include a total of 480
eligible patients.
6.2 Statistical Analysis Methods
All statistical tests will be two-tailed, and a P-value < 0.05 will be considered
statistically significant (unless otherwise specified). Quantitative indicators will be
described using mean, standard deviation, median, minimum, maximum, and
interquartile range (Q1, Q3), while categorical indicators will be described using
frequencies and percentages. Group comparisons will employ the independent
samples t-test (for normally distributed data with homogeneity of variance) or the
Wilcoxon rank-sum test for quantitative data, the Chi-square test or Fisher’s exact test
for categorical data, and the Wilcoxon rank-sum test or CMH test for ordinal data.
Enrollment and baseline characteristics, including demographic data, medical history,
and dropout reasons, will be analyzed using the Full Analysis Set (FAS) to ensure
group comparability. For primary efficacy endpoints (inflammatory markers), a
superiority (non-inferiority/equivalence) design will be utilized with a hypothesis of
H0: Ptreatment - Pcontrol ≥0, H1: Ptreatment- Pcontrol < 0, and α = 0.025 (one-tailed), evaluated
using both FAS and the Per-Protocol Set (PPS). Secondary efficacy endpoints will be

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analyzed based on general statistical principles using FAS and PPS, while safety
analysis will be performed on the Safety Set (SS) through descriptive statistics.
Missing data will be handled according to the pre-specified Statistical Analysis Plan
(SAP) finalized before database lock, with primary efficacy data utilizing the most
conservative imputation methods. The analysis populations are defined as follows: the
FAS includes all randomized participants who received treatment based on the
Intention-To-Treat (ITT) principle; the PPS includes those who strictly adhered to the
protocol and completed all required assessments; and the SS includes all randomized
patients who received at least one dose of study medication and underwent at least
one safety evaluation.
7. Recording and Reporting of Adverse Events
(I) Definitions: An Adverse Event (AE) is defined as any untoward medical
occurrence in a study participant after receiving the study product, including
symptoms, signs, diseases, or abnormal laboratory findings, which does not
necessarily have a direct causal relationship with the treatment. A Serious Adverse
Event (SAE) refers to any untoward medical occurrence that results in death, is
life-threatening,
requires
inpatient
hospitalization
or prolongation
of
existing
hospitalization, results in persistent or significant disability or loss of function, or is a
congenital anomaly or birth defect. An Adverse Drug Reaction (ADR) refers to any
harmful and unintended response where a causal relationship between the study
product and the event is at least a reasonable possibility. (II) Assessment of Severity:
Severity is a qualitative evaluation of the intensity of the event and does not
necessarily reflect its clinical seriousness or relationship to the study drug. Grading
will be based on the NCI CTCAE 5.0 (Grade 1 to 5); if these criteria are inapplicable,
the investigator’s clinical judgment shall prevail. (III) Assessment of Causality: The
relationship between the AE and the study product will be categorized into five levels:
Definitely Related, Probably Related, Possibly Related, Possibly Unrelated, or
Definitely Unrelated. (IV) Recording: The investigator and designated personnel are
responsible for identifying, confirming, and recording all AEs and SAEs. (V)

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Reporting of SAEs: Any SAE, regardless of its relationship to the intervention, must
be reported to the Ethics Committee within 24 hours of awareness. (VI) Follow-up:
Following the initial report, investigators must proactively follow up on all AEs/SAEs
during subsequent contacts until the event is resolved, stabilized, otherwise explained,
or the participant withdraws from the study.
8. Ethical and Regulatory Considerations
This study will be conducted in strict accordance with the Declaration of
Helsinki and all relevant international and domestic policies and regulations.
Investigators and research personnel must be familiar with and strictly adhere to the
study protocol while pre-establishing and executing effective risk prevention and
control measures. Prior to implementation, the study protocol, informed consent
forms, and other necessary documents must be submitted to and approved by the
Institutional Review Board (IRB). Furthermore, the study will be registered with the
Medical Research Registration and Filing Information System of the National Health
Commission
to
ensure
compliance
and
transparency.
For
approved
studies,
investigators are required to submit timely reports regarding study progress, serious
adverse events (SAEs), protocol deviations, suspensions, terminations, and study
completion. Regarding the Informed Consent Process, a structured plan must be
established to define who, when, where, and how consent is obtained. Specifically: 1)
Personnel obtaining consent must be appropriately qualified and ensure sufficient
time is allocated for the process; 2) The location for obtaining consent must ensure
participant privacy; 3) Consent must be obtained from the participant personally or
their legal guardian; 4) The method of consent (written, electronic remote, or
telephonic) must be specified, and if remote methods are used, rigorous procedures
for recording and archiving process documentation must be implemented.
9. Study Management

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(I) Protocol Amendments: Any modifications to the approved protocol, informed
consent forms, recruitment materials, or other participant-facing documents must be
submitted to the Ethics Committee (EC) as "Amendments" for review. All revisions,
whether major or minor, must be documented in writing; substantial amendments
affecting participant safety, study scope, or scientific quality require formal EC
approval. Emergencies requiring immediate protocol deviations to eliminate hazards
to participants may be implemented instantly but must be reported to the EC as soon
as possible. Minor administrative changes, such as updates to contact information or
study centers, do not require formal approval but must be filed with the EC for
record-keeping. (II) Quality Control: Designated personnel will perform quality
control (QC) throughout the study, ensuring that: 1) formal EC approval and
regulatory filings are obtained prior to implementation; 2) all researchers receive
standardized training to ensure uniform recording and judgment criteria; 3) enrolled
participants strictly meet all inclusion and exclusion criteria; 4) Case Report Forms
(CRFs) are filled out accurately and authentically; 5) all observations and findings are
verified to ensure data reliability and traceability; and 6) all SAEs and major protocol
deviations are reported to the EC promptly. (III) Premature Termination: The study
may be terminated prematurely if: 1) serious safety concerns are identified; 2) the
study drug demonstrates insufficient efficacy or lack of clinical value; 3) significant
design flaws or severe protocol deviations (e.g., violations of randomization or
medication protocols) render the assessment of drug effects impossible; or 4)
regulatory authorities mandate the termination of the research.
10. Research Implementation Conditions
Capital Medical University Xuanwu Hospital provides full support for this study,
including the necessary research premises, equipment, and facilities required to fulfill
the research tasks. The Principal Investigator and the research team possess the
requisite qualifications, professional expertise, experience, and technical capabilities
essential for the study. Furthermore, team members hold appropriate medical practice

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qualifications and extensive clinical experience, ensuring the safety and medical care
of study participants. All designated team members are qualified or have been
specifically trained to handle the informed consent process and remain available to
address any inquiries regarding safety issues at any time.
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