Metabolic SyndromePhase 3TORCH-metNCT06908473

Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients

A Phase 3 study testing Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. in people with Metabolic Syndrome and Cardiovascular Disease (CKD), run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

1. Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS). 2. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Metabolic Syndrome, Cardiovascular Disease (CKD), Cerebrovascular Disease
What is being tested?: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 530 participants
Where: 1 siteChina
Study dates: 24 Apr 2025to 31 Jul 2028
Phase: Phase 3
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age: Participants must be aged ≥65 years.
Participants must meet the diagnostic criteria for metabolic syndrome according to the 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at least three of the following criteria:①Central obesity: Waist circumference ≥90 cm for men, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoing treatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis of hypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70 mmol/L.
Low HDL cholesterol: Fasting HDL-C <1.04 mmol/L.
Participants must meet the criteria for "Qi-deficiency and Blood Stasis" syndrome, which includes specific symptoms and signs such as fatigue, shortness of breath, stabbing pain, ecchymosis, and a tongue with purple discoloration or petechiae.
High Cardiovascular Risk: Participants must have at least one of the following:
History of myocardial infarction.

Show all 9Show fewer

History of stroke or transient ischemic attack. ③History of coronary, carotid, or peripheral artery revascularization.
Coronary, carotid, or lower limb artery stenosis >50%. ⑤Positive exercise stress test or documented symptomatic coronary heart disease, or unstable angina with ECG changes.
Chronic heart failure (NYHA Class II-III). ⑦Chronic kidney disease (eGFR <60 ml/min/1.73m²).

Who cannot join

Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or blood glucose.
Type 1 Diabetes: Participants with Type 1 diabetes mellitus.
Special Populations: Pregnant or breastfeeding individuals, or those with a history of allergy to the study medication.
Recent Acute Events: Acute coronary or cerebrovascular events within the past 14 days.
Upcoming Revascularization: Planned coronary, carotid, or peripheral artery revascularization.
Severe Heart Failure: Chronic heart failure (NYHA Class IV).

Show all 10Show fewer

End-Stage Liver Disease: Participants with end-stage liver disease.
Solid Organ Transplantation: History of solid organ transplantation or awaiting solid organ transplantation.
Malignant Tumors: Participants with a history of malignant tumors.
Other Serious Conditions: Any other serious medical conditions that may interfere with the study or pose a risk to the participant.

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 Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510405

Other trials in China

About this study

Official title: A Multicenter, Double-Blind, Randomized Controlled Study on the Impact of Tongmai Jiangtang Capsules on the Risk of Cardiovascular and Cerebrovascular Events in Metabolic Syndrome

Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS).
Further construct an evaluation system for the long-term cardiovascular and cerebrovascular benefits of traditional Chinese medicine in regulating glucose and lipid metabolism through the evaluative study of the cardiovascular and cerebrovascular benefits of TJC.

Conditions: Metabolic Syndrome, Cardiovascular Disease (CKD), Cerebrovascular Disease, Qi Deficiency and Blood Stasis
Being tested: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment., A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC
Keywords: Metabolic Syndrome, High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS, Qi-Deficiency and Blood Stasis Syndrome, Tongmai Jiangtang Capsule
Medical subject headings: Metabolic Syndrome, Cardiovascular Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.Drug
Intervention Agent: The study employs Tongmai Jiangtang Capsule (TJC), a traditional Chinese medicine compound formulated based on TCM theory. It has the functions of Nourishing Yin, clearing heat and activating blood circulation, and can comprehensively regulate glucose and lipid metabolism as well as improve cardiovascular and cerebrovascular functions.
Intervention Population: The study focuses on patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS) who meet the TCM criteria for "Qi-deficiency and Blood Stasis syndrome," reflecting personalized and precision intervention.
Intervention Design: A long-term study design with 26 weeks of intervention followed by 26 weeks of follow-up is adopted to comprehensively assess the short-term efficacy and long-term cardiovascular benefits of TJC.
Control Design: The study employs a double-blind, randomized, placebo-controlled method.
A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJCDrug
Participants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment.

Study groups in NCT06908473
Study group	Role	What they receive
Experimental Group (Tongmai Jiangtang Capsule Group)	Experimental	Participants in this Arm will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. Dosage: Three capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm aims to evaluate the efficacy of TJC in reducing cardiovascular and cerebrovascular event risks in patients with metabolic syndrome at high cardiovascular risk (HCR-MS). Participants will adhere to the study protocol, attending regular visits and examinations to assess efficacy and safety. Receives: Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.
Control Group (Placebo Group)	Placebo comparator	Participants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment. Dosage: Three placebo capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm serves as a control to compare the efficacy of TJC against a placebo. Participants will adhere to the study protocol, attending regular visits and examinations to assess the efficacy and safety of the placebo. Receives: Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiovascular death
sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.
Measured: From enrollment to the next 52 weeks
Non-fatal myocardial infarction
Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction
Measured: From enrollment to the next 52 weeks
Non-fatal stroke
Meet any one of the following criteria:
- Acute neurological dysfunction documented by CT/MRI, attributable to vascular causes with other etiologies excluded; ② Transient ischemic attack (TIA) lasting <24 hours; ③ Microhemorrhage: Round hypointense lesions <5-10 mm on MRI.
Measured: From enrollment to the next 52 weeks

Secondary outcomes (17)

Composite cardiovascular outcomes
death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina or heart failure
Measured: From enrollment to the next 52 weeks
All-cause mortality
Any cause of death
Measured: From enrollment to the next 52 weeks
Renal and diabetes-related microvascular composite outcomes
Including renal outcomes or diabetic retinopathy outcomes
Measured: From enrollment to the next 52 weeks
blood glucose
Including fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2h PPG), and glycated hemoglobin (HbA1c).
Measured: From enrollment to the next 52 weeks
lipids
Including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Measured: From enrollment to the next 52 weeks
Blood pressure
Including systolic blood pressure and systolic blood pressure
Measured: From enrollment to the next 52 weeks
BMI
Body Mass Index
Measured: From enrollment to the next 52 weeks
waist-to-hip ratio
waist-to-hip ratio
Measured: From enrollment to the next 52 weeks
HOMA-IR
HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5
Measured: From enrollment to the next 52 weeks
Body fat analysis
Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI)
Measured: From enrollment to the next 52 weeks
Vitamin D levels
Vitamin D levels
Measured: From enrollment to the next 52 weeks
Assessment of peripheral vascular status
Assessment of plaque or stenosis in the common carotid artery
Measured: From enrollment to the next 52 weeks
Cardiac function
Including Cardiac Enzymes, Troponin, BNP, Ejection Fraction (EF), Left Ventricular Myocardial Thickness, and Interventricular Septal Thickness.
Measured: From enrollment to the next 52 weeks
Cardiovascular risk indices
Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score.
Measured: From enrollment to the next 52 weeks
Traditional Chinese medicine symptom scores
Including symptoms related to observation, hearing, questioning, and palpation.
Measured: From enrollment to the next 52 weeks
Quality of life scores.
The Short-From-36 Health Survey, SF-36
Measured: From enrollment to the next 52 weeks
Omics analysis
Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis.
Measured: From enrollment to the next 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 202531 Jul 2028

First posted3 Apr 2025
Study start24 Apr 2025
Primary completion31 Jul 2028 (estimated)
Study completion31 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 530 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06908473
Sponsor's protocol ID: ZLiu
Acronym: TORCH-met
Status last verified: Jun 2025
First submitted: 15 Mar 2025
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.
PubMed 24176437
Li A, Ma Y, Chen Z, Lu Q, Liu C, Zhou P, Liang Q, Tao Y, Chen M, Chen Z, Luo F, Lei X, Liu S, Long J, Xiao H, Cui C, Ren Q, Liu Y, Zhong T, Liu J, Fan G, Liu Y, Hui Z, Chen Q, Liu Z. A protocol for the impact of Tongmai Jiangtang capsules on the risk of cardiovascular and cerebrovascular events in metabolic syndrome. Front Cardiovasc Med. 2026 Jul 28;13:1817298. doi: 10.3389/fcvm.2026.1817298. eCollection 2026.
PubMed 42582064

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized Controlled Study on the Impact of Tongmai Jiangtang Capsules on the Risk of Cardiovascular and Cerebrovascular Events in Metabolic Syndrome
ClinicalTrials.gov ID: NCT06908473
Acronym / sponsor ID: TORCH-met / ZLiu
Conditions: Metabolic Syndrome, Cardiovascular Disease (CKD), Cerebrovascular Disease, Qi Deficiency and Blood Stasis
Keywords: Metabolic Syndrome, High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS, Qi-Deficiency and Blood Stasis Syndrome, Tongmai Jiangtang Capsule
Phase: Phase 3
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 530 participants (estimated)
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
Collaborators: TCM hospital of Sichuan Province, Xiyuan Hospital of CACMS, Shaanxi Provincial Hospital of Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd
Study start: 24 Apr 2025 (actual)
Primary completion: 31 Jul 2028 (estimated)
Study completion: 31 Jul 2028 (estimated)
First posted: 3 Apr 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.

Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS).
Further construct an evaluation system for the long-term cardiovascular and cerebrovascular benefits of traditional Chinese medicine in regulating glucose and lipid metabolism through the evaluative study of the cardiovascular and cerebrovascular benefits of TJC.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental Group (Tongmai Jiangtang Capsule Group)	Experimental	Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.Participants in this Arm will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. Dosage: Three capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm aims to evaluate the efficacy of TJC in reducing cardiovascular and cerebrovascular event risks in patients with metabolic syndrome at high cardiovascular risk (HCR-MS). Participants will adhere to the study protocol, attending regular visits and examinations to assess efficacy and safety.
Control Group (Placebo Group)	Placebo comparator	Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJCParticipants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment. Dosage: Three placebo capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm serves as a control to compare the efficacy of TJC against a placebo. Participants will adhere to the study protocol, attending regular visits and examinations to assess the efficacy and safety of the placebo.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (9 listed)

Age: Participants must be aged ≥65 years.
Participants must meet the diagnostic criteria for metabolic syndrome according to the 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at least three of the following criteria:①Central obesity: Waist circumference ≥90 cm for men, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoing treatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis of hypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70 mmol/L.
Low HDL cholesterol: Fasting HDL-C <1.04 mmol/L.
Participants must meet the criteria for "Qi-deficiency and Blood Stasis" syndrome, which includes specific symptoms and signs such as fatigue, shortness of breath, stabbing pain, ecchymosis, and a tongue with purple discoloration or petechiae.
High Cardiovascular Risk: Participants must have at least one of the following:

Key exclusion criteria (10 listed)

Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or blood glucose.
Type 1 Diabetes: Participants with Type 1 diabetes mellitus.
Special Populations: Pregnant or breastfeeding individuals, or those with a history of allergy to the study medication.
Recent Acute Events: Acute coronary or cerebrovascular events within the past 14 days.
Upcoming Revascularization: Planned coronary, carotid, or peripheral artery revascularization.

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
Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.Intervention Agent: The study employs Tongmai Jiangtang Capsule (TJC), a traditional Chinese medicine compound formulated based on TCM theory. It has the functions of Nourishing Yin, clearing heat and activating blood circulation, and can comprehensively regulate glucose and lipid metabolism as well as improve cardiovascular and cerebrovascular functions. Intervention Population: The study focuses on patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS) who meet the TCM criteria for "Qi-deficiency and Blood Stasis syndrome," reflecting personalized and precision intervention. Intervention Design: A long-term study design with 26 weeks of intervention followed by 26 weeks of follow-up is adopted to comprehensively assess the short-term efficacy and long-term cardiovascular benefits of TJC. Control Design: The study employs a double-blind, randomized, placebo-controlled method.	Drug	Experimental Group (Tongmai Jiangtang Capsule Group)
A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJCParticipants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment.	Drug	Control Group (Placebo Group)

Primary outcome

Cardiovascular death
Time frame: From enrollment to the next 52 weeks
sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.
Non-fatal myocardial infarction
Time frame: From enrollment to the next 52 weeks
Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction
Non-fatal stroke
Time frame: From enrollment to the next 52 weeks
Meet any one of the following criteria: * Acute neurological dysfunction documented by CT/MRI, attributable to vascular causes with other etiologies excluded; ② Transient ischemic attack (TIA) lasting <24 hours; ③ Microhemorrhage: Round hypointense lesions <5-10 mm on MRI.

17 secondary outcomes

Composite cardiovascular outcomes
Time frame: From enrollment to the next 52 weeks
All-cause mortality
Time frame: From enrollment to the next 52 weeks
Renal and diabetes-related microvascular composite outcomes
Time frame: From enrollment to the next 52 weeks
blood glucose
Time frame: From enrollment to the next 52 weeks
lipids
Time frame: From enrollment to the next 52 weeks
Blood pressure
Time frame: From enrollment to the next 52 weeks
BMI
Time frame: From enrollment to the next 52 weeks
waist-to-hip ratio
Time frame: From enrollment to the next 52 weeks
HOMA-IR
Time frame: From enrollment to the next 52 weeks
Body fat analysis
Time frame: From enrollment to the next 52 weeks
Vitamin D levels
Time frame: From enrollment to the next 52 weeks
Assessment of peripheral vascular status
Time frame: From enrollment to the next 52 weeks
Cardiac function
Time frame: From enrollment to the next 52 weeks
Cardiovascular risk indices
Time frame: From enrollment to the next 52 weeks
Traditional Chinese medicine symptom scores
Time frame: From enrollment to the next 52 weeks
Quality of life scores.
Time frame: From enrollment to the next 52 weeks
Omics analysis
Time frame: From enrollment to the next 52 weeks

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 13 Jun 2025.
Results publication: PubMed 24176437Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.
Derived from this study: PubMed 42582064Li A, Ma Y, Chen Z, Lu Q, Liu C, Zhou P, Liang Q, Tao Y, Chen M, Chen Z, Luo F, Lei X, Liu S, Long J, Xiao H, Cui C, Ren Q, Liu Y, Zhong T, Liu J, Fan G, Liu Y, Hui Z, Chen Q, Liu Z. A protocol for the impact of Tongmai Jiangtang capsules on the risk of cardiovascular and cerebrovascular events in metabolic syndrome. Front Cardiovasc Med. 2026 Jul 28;13:1817298. doi: 10.3389/fcvm.2026.1817298. eCollection 2026.
Individual participant dataSharing planned: Yes

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 13 Jun 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular death (time frame: From enrollment to the next 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908473, which also lists 2 linked publications.

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 13 Jun 2025.