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

NCT07351643 | Not Yet Recruiting Phase 4

• 2 other identifiers: SYNH-Y2025503Y(2025)503
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ACS (Acute Coronary Syndrome); SGLT2 Inhibitors

Keywords

Fat attenuation index; SGLT2 inhibitors; Pericoronary adipose tissue; Residual inflammatory risk; Coronary CT angiography

Outcome Measures

Primary Outcomes (1)

• Changes in FAI from baseline to 6 months in patients assessed by CCTA

  Change in FAI of major coronary arteries (left main \[LM\], right coronary artery \[RCA\], left anterior descending \[LAD\], and left circumflex \[LCX\]) from baseline to 6 months, expressed in Hounsfield Units (HU), assessed at the patient level.

  From randomization to 6 months post-randomization

Secondary Outcomes (6)

• Change in total plaque volume

  From randomization to 6 months post-randomization

• Change in calcified plaque volume

  From baseline (at randomization) to 6 months post-randomization

• Change in fibrous plaque volume

  From baseline (at randomization) to 6 months post-randomization

• Change in fibrofatty plaque volume

  From baseline (at randomization) to 6 months post-randomization

• Change in low-attenuation plaque volume

  From baseline (at randomization) to 6 months post-randomization

Study Arms (2)

Dapagliflozin group

EXPERIMENTAL

Participants receive dapagliflozin 10 mg orally once daily in addition to guideline-directed medical therapy for 6 months.

Drug: Dapagliflozin

Non-dapagliflozin group

NO INTERVENTION

Participants receive guideline-directed medical therapy alone without any SGLT2 inhibitor for 6 months.

Interventions

Dapagliflozin DRUG

10 mg/d for 6 months

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina)
• Undergoing percutaneous coronary intervention (PCI)
• Presence of multivessel coronary artery disease with at least one non-culprit vessel not undergoing revascularization (for CCTA follow-up assessment)
• Willing and able to provide written informed consent

You may not qualify if:

• Prior or current diagnosis of diabetes mellitus
• Prior or current diagnosis of chronic heart failure
• Treatment with any SGLT2 inhibitor within 4 weeks prior to enrollment
• Severe hepatic impairment
• History of recurrent urogenital infections
• Known allergy or intolerance to SGLT2 inhibitors
• Pregnancy or breastfeeding
• Systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg
• Severe chronic kidney disease (eGFR \<30 mL/min/1.73 m²)
• Current participation in another interventional clinical trial
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for enrollment

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Eligible participants will undergo CCTA at 1 month after PCI. Those meeting all criteria will then be randomized 1:1 to the dapagliflozin group or standard care group using a dynamic block randomization method.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 20, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)