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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin: 10 mg/d for 6 months

Study summary

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

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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