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

January 12, 2026 updated by: Han Yaling, Shenyang Northern Hospital

Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Non-diabetic ACS Patients Without Heart Failure Using CCTA

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

SCIENTIFIC BACKGROUND

Residual inflammatory risk (RIR) has emerged as a major driver of adverse cardiovascular outcomes in patients with acute coronary syndrome (ACS), even after guideline-directed medical therapy and successful revascularization. Recent pooled analyses of the PROMINENT, REDUCE-IT, and STRENGTH trials demonstrated that high-sensitivity C-reactive protein (hsCRP), a marker of RIR, predicts future cardiovascular events more strongly than LDL-cholesterol in statin-treated patients.

Pericoronary adipose tissue (PCAT) fat attenuation index (FAI), measured by coronary CT angiography (CCTA), has been validated as a novel imaging biomarker that directly quantifies coronary artery inflammation. When coronary inflammation occurs, PCAT undergoes characteristic morphological changes with decreased lipid content and increased water-to-fat ratio, resulting in higher CT attenuation values (shifting from approximately -190 Hounsfield Units toward -30 HU). The CRISP-CT study validated this imaging biomarker and demonstrated its prognostic value for cardiac mortality independent of conventional cardiovascular risk factors.

SGLT2 inhibitors have established cardiovascular benefits in patients with diabetes or heart failure. Beyond glucose-lowering and diuretic effects, anti-inflammatory mechanisms may contribute to these benefits, including suppression of inflammatory cytokines such as interleukin-6 and monocyte chemoattractant protein-1, reduction of oxidative stress, and improvement of endothelial function. Clinical studies have shown that SGLT2 inhibitors reduce epicardial adipose tissue volume and may stabilize coronary plaques in diabetic patients. The EMPA-TROPISM study provided evidence that empagliflozin reduces epicardial adipose tissue volume even in non-diabetic patients with heart failure, suggesting glucose-independent mechanisms.

KNOWLEDGE GAP

The EMPACT-MI and DAPA-MI trials recently evaluated SGLT2 inhibitors in patients with acute myocardial infarction without diabetes or heart failure, with primary endpoints focused on clinical outcomes. Neither trial specifically assessed coronary inflammation using validated imaging biomarkers. Whether SGLT2 inhibitors exert measurable anti-inflammatory effects at the coronary arterial level in this population remains unknown.

STUDY RATIONALE

This study addresses this knowledge gap by employing CCTA-derived pericoronary fat attenuation index as a direct measure of coronary inflammation. The study population specifically excludes patients with diabetes and heart failure to isolate the potential anti-inflammatory effects of dapagliflozin from its established benefits in these conditions. Assessment of non-culprit vessels in patients with multivessel disease allows longitudinal evaluation of atherosclerotic changes without interference from prior intervention.

STUDY TIMELINE

Participants undergo PCI for ACS at enrollment. At 1 month post-PCI, eligible participants undergo baseline CCTA and are then randomized to receive either dapagliflozin plus standard therapy or standard therapy alone. This timing allows for stabilization of the acute coronary event before baseline imaging assessment. Follow-up CCTA is performed at 6 months post-randomization to evaluate changes in FAI and plaque characteristics.

CLINICAL SIGNIFICANCE

Current anti-inflammatory therapies for secondary prevention of coronary artery disease have significant limitations, including high cost and limited accessibility for monoclonal antibodies such as canakinumab, and gastrointestinal side effects with poor tolerability for low-dose colchicine. If this study demonstrates that SGLT2 inhibitors reduce coronary inflammation in non-diabetic patients without heart failure, it would expand therapeutic options for addressing residual inflammatory risk and potentially benefit a broader patient population beyond those with diabetes or heart failure.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • General Hospital of Northern Theater Command
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin group
Participants receive dapagliflozin 10 mg orally once daily in addition to guideline-directed medical therapy for 6 months.
Drug: Dapagliflozin
10 mg/d for 6 months
No Intervention: Non-dapagliflozin group
Participants receive guideline-directed medical therapy alone without any SGLT2 inhibitor for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in FAI from baseline to 6 months in patients assessed by CCTA
Time Frame: From randomization to 6 months post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total plaque volume
Time Frame: From randomization to 6 months post-randomization
Absolute change in total coronary plaque volume (mm³)
From randomization to 6 months post-randomization
Change in calcified plaque volume
Time Frame: From baseline (at randomization) to 6 months post-randomization
Absolute change in calcified plaque volume (mm³)
From baseline (at randomization) to 6 months post-randomization
Change in fibrous plaque volume
Time Frame: From baseline (at randomization) to 6 months post-randomization
Absolute change in fibrous plaque volume (mm³)
From baseline (at randomization) to 6 months post-randomization
Change in fibrofatty plaque volume
Time Frame: From baseline (at randomization) to 6 months post-randomization
Absolute change in fibrofatty plaque volume (mm³)
From baseline (at randomization) to 6 months post-randomization
Change in low-attenuation plaque volume
Time Frame: From baseline (at randomization) to 6 months post-randomization
Absolute change in low-attenuation plaque volume (mm³)
From baseline (at randomization) to 6 months post-randomization
Change in coronary stenosis
Time Frame: From baseline (at randomization) to 6 months post-randomization
Absolute change in degree of coronary artery stenosis (%)
From baseline (at randomization) to 6 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 25, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNH-Y2025503
  • Y(2025)503 (Other Identifier: Northern Theater Command General Hospital Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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