Diabete MellitusPhase 4TICDEsNCT07088523
Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study
A Phase 4 study testing Xintong Oral Liquid (Sequential Phase), Xintong Oral Liquid (Intensive Phase) and TCM Syndrome Differentiation Decoction in people with Diabete Mellitus and Ischemic Cardiovascular Disease, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The population with comorbid ischemic cardiovascular disease (ICD) and diabetes mellitus (DM) has been growing rapidly, characterized by high mortality rates and frequent vascular event recurrence. DM exacerbates ischemic heart disease incidence and significantly elevates mortality in this comorbid population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabete Mellitus, Ischemic Cardiovascular Disease
- What is being tested?
- Xintong Oral Liquid (Sequential Phase), Xintong Oral Liquid (Intensive Phase) and TCM Syndrome Differentiation Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,205 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years;
- Met the diagnostic criteria for myocardial infarction and type 2 diabetes mellitus;
- Within 72 hours of myocardial infarction onset;
- Met the diagnostic criteria of "toxins damaging collaterals"；
- Voluntary participation in the study with consent forms signed.
Who cannot join
- Long-term (>20 min) cardio-pulmonary resuscitation (CPR);
- Critical illness due to STEMI (such as serious cardiogenic shock, uncontrolled acute left heart failure or pulmonary edema, malignant arrhythmias, explicit mechanical complications, etc. );
- Suspected aortic dissection or acute pulmonary embolism;
- Bleeding history in any organ system within 1 month, or presence of active hemorrhage at any part of the body, or known hemorrhagic constitution, or severe coagulation disorder or current usage of anticoagulants;
- Uncontrolled severe diabetic ketoacidosis;
- Serious hepatic dysfunction or serious renal dysfunction ( ALT/AST≥3 ULN or eGFR<30mL/min/1.73 m2 or equiring dialysis );
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- Serious COPD or respiratory failure;
- Severe infection (such as positive blood cultures, septic shock, and septic pneumonia, etc.);
- Neuropsychiatric system diseases or unconscious and unable to cooperate with examination and treatment;
- Malignancies or other conditions with expected survival time<1 year or unsuitability to participate in this study due to other diseases;
- Allergy to the ingredients of the research drugs;
- Women who are in pregnancy or nursery;
- Participation in clinical trial of other traditional Chinese medicine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, 510120
Tao Huang, doctor, 18688898958, arteries@163.com
Zheng Zhen, master, 19120517600, devotetcm@163.com
About this study
The population with comorbid ischemic cardiovascular disease (ICD) and diabetes mellitus (DM) has been growing rapidly, characterized by high mortality rates and frequent vascular event recurrence. DM exacerbates ischemic heart disease incidence and significantly elevates mortality in this comorbid population. Polypharmacy in these patients increases risks of adverse drug interactions and imposes substantial healthcare burdens. The pathological mechanisms of comorbidity demonstrate significant alignment with the TCM. Experimental studies indicate that Xintong Oral Liquid can ameliorate myocardial ischemia through multiple mechanisms to improve vascular endothelial function and microvascular dysfunction. This study aims to investigate the long-term effects of TCM intervention in patients with comorbid ICD and DM within 72 hours of symptom onset, and to evaluate whether the TCM treatment approach-centered on Xintong Oral Liquid within an integrated general treatment and syndrome differentiation framework-demonstrates superiority over control therapy in reducing 90-day major adverse cardiovascular and cerebrovascular events (MACCEs).
Read the detailed description
This study is a large-scale, real-world, prospective, multi-center, non-randomized controlled clinical trail investigating the efficacy of a TCM therapeutic strategy with Xintong Oral Liquid as the core prescription in preventing major adverse cardiovascular and cerebrovascular events (MACCEs) in patients with Ischemic Cardiovascular Disease (ICD) complicated with Diabetes Mellitus (DM). This TCM therapeutic strategy is derived from the "toxins damaging collaterals" theory in TCM pathogenesis. All enrolled patients will receive standard treatment for ICD and DM based on the recommendations of guidelines. This study will employ natural selection grouping based on shared decision-making between physicians and patients, utilizing an open-label design with blinded endpoint assessment. An independent third-party endpoint adjudication committee will be established to conduct impartial evaluation and determination of all endpoint events. The study objective is to determine the following therapeutic effects of Xintong Oral Liquid as compared with standard treatment in the treatment of patients with ICD ccomplicated with DM: (1) 90-days incidence of the composite endpoints of major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, myocardial re-infarction, emergent coronary revascularization and stroke; severe complications of STEMI (including cardiogenic shock, acute left heart failure, mechanical complications and malignant arrhythmias), in-stent thrombosis and major bleeding (Bleeding Academic Research Consortium [BARC] grade III and V); (2) Individual event of the 90-day primary endpoint; severe STEMI complications within 30-day treatment; target vessel failure (TVF) rate of PCI; MACCEs at 30, 180 and 365 days; follow-up assessments of SAQ-7 and EQ-5D-5L; the rate of readmission for heart failure; diabetic microangiopathy.
- Conditions
- Diabete Mellitus, Ischemic Cardiovascular Disease
- Being tested
- Xintong Oral Liquid (Sequential Phase), Xintong Oral Liquid (Intensive Phase), TCM Syndrome Differentiation Decoction, Standard Treatment (Guideline-Based)
- Keywords
- Diabete Mellitus, Ischemic cardiovascular disease, real-world, Xintong Oral Liquid
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xintong Oral Liquid (Sequential Phase)Drug
Xintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52.
Xintong Oral Liquid (Intensive Phase)Drug
Xintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks.
TCM Syndrome Differentiation DecoctionDrug
Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
Standard Treatment (Guideline-Based)Drug
Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). *Doses may be adjusted per local guidelines or patient tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Xintong TCM + Standard Treatment | Experimental | 1. Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks.
2. Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52.
3. TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase. Receives: Drug: Xintong Oral Liquid (Sequential Phase); Drug: Xintong Oral Liquid (Intensive Phase); Drug: TCM Syndrome Differentiation Decoction |
| Standard Treatment Only | Active comparator | Guideline-based treatment for AMI with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion. Receives: Drug: Standard Treatment (Guideline-Based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs)
Composite of: 1) Myocardial re-infarction (Third Universal Definition of MI); 2) Emergent coronary revascularization; 3) Stroke (NIHSS ≥1, imaging-confirmed); 4) Cardiovascular death (adjudicated by endpoint committee).
Measured: 90 days
Secondary outcomes (8)
30-day Severe STEMI Complications (Killip Class II-IV)
Composite of: 1) Cardiogenic shock (Killip IV); 2) Acute heart failure (Killip II-III); 3) Mechanical complications (e.g., ventricular septal rupture); 4) Malignant arrhythmia (sustained VT/VF). Assessed by adjudication committee.
Measured: 30 days
30-day Severe Bleeding (BARC Type 3 or 5)
Bleeding Academic Research Consortium (BARC) criteria: Type 3 (overt bleeding with hemoglobin drop ≥3 g/dL or transfusion) or Type 5 (fatal bleeding).
Measured: 30 days
365-day Target Vessel Failure (TVF) Rate
Composite of: 1) Cardiac death; 2) Target vessel myocardial infarction; 3) Target vessel revascularization (TVR). Angiographically confirmed by core lab.
Measured: 365 days
Change in LVEF (%) from Baseline to 90 days
Left ventricular ejection fraction measured by echocardiography (Simpson's biplane method).
Measured: Baseline, 90 days
Change in TyG Index from Baseline to 90 days
Triglyceride-glucose index calculated as ln[fasting triglycerides (mg/dL) × fasting glucose (mg/dL)/2].
Measured: Baseline, 90 days
SAQ-7 Angina Frequency Score at baseline, 3, 6, 12 Months
Seattle Angina Questionnaire (SAQ-7) Domain 1 (Angina Frequency). Scale: 0-100 (higher=better).
Measured: Baseline, 3, 6, 12 Months
EQ-5D-5L Utility Score at baseline, 3, 6, 12 Months
EuroQol 5-Dimension 5-Level (EQ-5D-5L) health-related quality of life. Scale: 0-1 (higher=better).
Measured: Baseline, 3, 6, 12 Months
Heart Failure Readmission Rate at 180 Days and 365 Days
Proportion of participants hospitalized for worsening heart failure (per modified Framingham criteria) within 180 days and 365 days post-treatment. Adjudicated by blinded Clinical Events Committee.
Measured: 180 days, 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088523
- Sponsor's protocol ID
- 2023ZD0505604plus
- Acronym
- TICDEs
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) underlying the results of this study will not be shared publicly due to: 1. Ethical and Legal Restrictions: The study involves sensitive health data of patients with acute myocardial infarction and diabetes, which are protected. Informed consent documents did not include provisions for public data sharing. 2. Institutional Policies: Our institution's data governance framework requires that participant data be retained securely and used only for pre-specified research purposes. 3. Practical Limitations: Anonymization of complex clinical datasets (e.g., including imaging, lab results, and follow-up records) cannot fully eliminate re-identification risks. Requests for de-identified data may be considered on a case-by-case basis for legitimate research purposes, subject to institutional review and data transfer agreements.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study
- ClinicalTrials.gov ID
- NCT07088523
- Acronym / sponsor ID
- TICDEs / 2023ZD0505604plus
- Conditions
- Diabete Mellitus, Ischemic Cardiovascular Disease
- Keywords
- Diabete Mellitus, Ischemic cardiovascular disease, real-world, Xintong Oral Liquid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,205 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The population with comorbid ischemic cardiovascular disease (ICD) and diabetes mellitus (DM) has been growing rapidly, characterized by high mortality rates and frequent vascular event recurrence. DM exacerbates ischemic heart disease incidence and significantly elevates mortality in this comorbid population. Polypharmacy in these patients increases risks of adverse drug interactions and imposes substantial healthcare burdens. The pathological mechanisms of comorbidity demonstrate significant alignment with the TCM. Experimental studies indicate that Xintong Oral Liquid can ameliorate myocardial ischemia through multiple mechanisms to improve vascular endothelial function and microvascular dysfunction. This study aims to investigate the long-term effects of TCM intervention in patients with comorbid ICD and DM within 72 hours of symptom onset, and to evaluate whether the TCM treatment approach-centered on Xintong Oral Liquid within an integrated general treatment and syndrome differentiation framework-demonstrates superiority over control therapy in reducing 90-day major adverse cardiovascular and cerebrovascular events (MACCEs).
Detailed description
This study is a large-scale, real-world, prospective, multi-center, non-randomized controlled clinical trail investigating the efficacy of a TCM therapeutic strategy with Xintong Oral Liquid as the core prescription in preventing major adverse cardiovascular and cerebrovascular events (MACCEs) in patients with Ischemic Cardiovascular Disease (ICD) complicated with Diabetes Mellitus (DM). This TCM therapeutic strategy is derived from the "toxins damaging collaterals" theory in TCM pathogenesis. All enrolled patients will receive standard treatment for ICD and DM based on the recommendations of guidelines. This study will employ natural selection grouping based on shared decision-making between physicians and patients, utilizing an open-label design with blinded endpoint assessment. An independent third-party endpoint adjudication committee will be established to conduct impartial evaluation and determination of all endpoint events. The study objective is to determine the following therapeutic effects of Xintong Oral Liquid as compared with standard treatment in the treatment of patients with ICD ccomplicated with DM: (1) 90-days incidence of the composite endpoints of major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, myocardial re-infarction, emergent coronary revascularization and stroke; severe complications of STEMI (including cardiogenic shock, acute left heart failure, mechanical complications and malignant arrhythmias), in-stent thrombosis and major bleeding (Bleeding Academic Research Consortium [BARC] grade III and V); (2) Individual event of the 90-day primary endpoint; severe STEMI complications within 30-day treatment; target vessel failure (TVF) rate of PCI; MACCEs at 30, 180 and 365 days; follow-up assessments of SAQ-7 and EQ-5D-5L; the rate of readmission for heart failure; diabetic microangiopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xintong TCM + Standard Treatment | Experimental | Drug: Xintong Oral Liquid (Sequential Phase), Drug: Xintong Oral Liquid (Intensive Phase), Drug: TCM Syndrome Differentiation Decoction1. Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks. 2. Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52. 3. TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase. |
| Standard Treatment Only | Active comparator | Drug: Standard Treatment (Guideline-Based)Guideline-based treatment for AMI with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18 years;
- Met the diagnostic criteria for myocardial infarction and type 2 diabetes mellitus;
- Within 72 hours of myocardial infarction onset;
- Met the diagnostic criteria of "toxins damaging collaterals"；
- Voluntary participation in the study with consent forms signed.
Key exclusion criteria (13 listed)
- Long-term (>20 min) cardio-pulmonary resuscitation (CPR);
- Critical illness due to STEMI (such as serious cardiogenic shock, uncontrolled acute left heart failure or pulmonary edema, malignant arrhythmias, explicit mechanical complications, etc. );
- Suspected aortic dissection or acute pulmonary embolism;
- Bleeding history in any organ system within 1 month, or presence of active hemorrhage at any part of the body, or known hemorrhagic constitution, or severe coagulation disorder or current usage of anticoagulants;
- Uncontrolled severe diabetic ketoacidosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xintong Oral Liquid (Sequential Phase)Xintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52. | Drug | Xintong TCM + Standard Treatment |
| Xintong Oral Liquid (Intensive Phase)Xintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks. | Drug | Xintong TCM + Standard Treatment |
| TCM Syndrome Differentiation DecoctionIndividualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase. | Drug | Xintong TCM + Standard Treatment |
| Standard Treatment (Guideline-Based)Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). *Doses may be adjusted per local guidelines or patient tolerance. | Drug | Standard Treatment Only |
Primary outcome
90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs)
Time frame: 90 days
Composite of: 1) Myocardial re-infarction (Third Universal Definition of MI); 2) Emergent coronary revascularization; 3) Stroke (NIHSS ≥1, imaging-confirmed); 4) Cardiovascular death (adjudicated by endpoint committee).
8 secondary outcomes
30-day Severe STEMI Complications (Killip Class II-IV)
Time frame: 30 days
30-day Severe Bleeding (BARC Type 3 or 5)
Time frame: 30 days
365-day Target Vessel Failure (TVF) Rate
Time frame: 365 days
Change in LVEF (%) from Baseline to 90 days
Time frame: Baseline, 90 days
Change in TyG Index from Baseline to 90 days
Time frame: Baseline, 90 days
SAQ-7 Angina Frequency Score at baseline, 3, 6, 12 Months
Time frame: Baseline, 3, 6, 12 Months
EQ-5D-5L Utility Score at baseline, 3, 6, 12 Months
Time frame: Baseline, 3, 6, 12 Months
Heart Failure Readmission Rate at 180 Days and 365 Days
Time frame: 180 days, 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) underlying the results of this study will not be shared publicly due to: 1. Ethical and Legal Restrictions: The study involves sensitive health data of patients with acute myocardial infarction and diabetes, which are protected. Informed consent documents did not include provisions for public data sharing. 2. Institutional Policies: Our institution's data governance framework requires that participant data be retained securely and used only for pre-specified research purposes. 3. Practical Limitations: Anonymization of complex clinical datasets (e.g., including imaging, lab results, and follow-up records) cannot fully eliminate re-identification risks. Requests for de-identified data may be considered on a case-by-case basis for legitimate research purposes, subject to institutional review and data transfer agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xintong Oral Liquid (Sequential Phase), Xintong Oral Liquid (Intensive Phase) and TCM Syndrome Differentiation Decoction in people with Diabete Mellitus and Ischemic Cardiovascular Disease, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Huang (18688898958, arteries@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.