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

Sponsor
Shenyang Northern Hospital
Study ID
NCT07351643
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • ACS (Acute Coronary Syndrome)
  • SGLT2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 25, 2026
Status verified
Jan 2026
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Changes in FAI from baseline to 6 months in patients assessed by CCTA [ Time Frame: From randomization to 6 months post-randomization ]