CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF
NCT07351643 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-01-20
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
Interventions
- DRUG
-
10 mg/d for 6 months
Sponsors & Collaborators
-
Shenyang Northern Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-25
- Primary Completion
- 2026-10-30
- Completion
- 2026-12-30
Countries
- China
Study Locations
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