DAPA-PCATNCT07351643

CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome

StatusRecruiting

PhasePhase 4

SponsorShenyang Northern Hospital

Primary completionJun 30, 2027 (estimated)

At risk: Primary completion moved 8 months later.

See at-risk trials from Shenyang Northern Hospital

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 27, 2026 Primary and study completion dates pushed to Jun 30, 2027 Show 6 more changesShow less
- Recruitment opened
- Start date changed from estimate of Feb 25, 2026 to Jun 25, 2026
- Eligibility criteria shortened, about 16 words
- Study description shortened, about 154 words
- Site details revised
- Study title revised
Jan 12, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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

Timeframe: From randomization to 6 months post-randomization

Secondary (6)

Change in total plaque volume

Change in calcified plaque volume

Change in fibrous plaque volume

Change in fibrofatty plaque volume

Change in low-attenuation plaque volume

Show 1 moreShow less

Change in coronary stenosis

Arms and interventions

Dapagliflozin groupExperimental

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

Non-dapagliflozin groupNo intervention

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

Drugs: Dapagliflozin

Sites

1 site in 1 country

General Hospital of Northern Theater CommandShenyang, Liaoning, China

About this trial

The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome. 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 randomisation. * Receive follow-up phone calls at 3 and 6 months after randomisation

Trial details

Enrollment: 110 participants (estimated)
Started: Jun 25, 2026
Study completion: Jun 30, 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Acute Coronary Syndrome, ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Official title: Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT
First posted: Jan 20, 2026
Registry updated: Oct 30, 2026
Last verified: Oct 2026

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