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Clinical Trials in China / NCT07351643
Starting soon Phase 4

CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF

NCT07351643 · tracked via the Priya Life Science China tracker
Sponsor
Shenyang Northern Hospital
Phase
Phase 4
Started
2026-02-25
Last updated
2026-01-20

Condition(s) studied

ACS (Acute Coronary Syndrome)SGLT2 Inhibitors

Investigational drug(s) / intervention(s)

Dapagliflozin

Dapagliflozin: 10 mg/d for 6 months

Study summary

The goal of this clinical trial is to learn if dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce coronary artery inflammation in people with acute coronary syndrome (ACS) who do not have diabetes or heart failure.

Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.

The main questions it aims to answer are:

* Does dapagliflozin lower coronary artery inflammation as measured by FAI?
* Does dapagliflozin slow the progression of coronary plaques?

Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.

Participants will:

* Undergo percutaneous coronary intervention (PCI) for ACS
* Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone
* Have a follow-up CCTA scan at 6 months after randomization
* Have blood tests at the time of PCI, at randomization, and at 6 months after randomization
* Receive follow-up phone calls at 3 and 6 months after randomization

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years 2. Diagnosis of acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina) 3. Undergoing percutaneous coronary intervention (PCI) 4. Presence of multivessel coronary artery disease with at least one non-culprit vessel not undergoing revascularization (for CCTA follow-up assessment) 5. Willing and able to provide written informed consent Exclusion Criteria: 1. Prior or current diagnosis of diabetes mellitus 2. Prior or current diagnosis of chronic heart failure 3. Treatment with any SGLT2 inhibitor within 4 weeks prior to enrollment 4. Severe hepatic impairment 5. History of recurrent urogenital infections 6. Known allergy or intolerance to SGLT2 inhibitors 7. Pregnancy or breastfeeding 8. Systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg 9. Severe chronic kidney disease (eGFR \<30 mL/min/1.73 m²) 10. Current participation in another interventional clinical trial 11. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for enrollment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Northern Theater Command Shenyang Liaoning

On this site

📄 Farxiga (dapagliflozin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351643 on ClinicalTrials.gov ↗ ← All trials in China