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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Northern Hospital

About this trial

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

Eligibility criteria

Qualifiers

Age ≥18 years

Diagnosis of acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina)

Undergoing percutaneous coronary intervention (PCI)

Presence of multivessel coronary artery disease with at least one non-culprit vessel not undergoing revascularization (for CCTA follow-up assessment)

Disqualifiers

Prior or current diagnosis of diabetes mellitus

Prior or current diagnosis of chronic heart failure

Treatment with any SGLT2 inhibitor within 4 weeks prior to enrollment

Severe hepatic impairment

Trial design

Treatments tested in this trial

  • Dapagliflozin

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators