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NCT07351643
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
Conditions: ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 110
Sponsor: Shenyang Northern Hospital
Location: General Hospital of Northern Theater Command Shenyang Liaoning
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 Criteria
Inclusion Criteria
1. Aged ≥ 18 years, irrespective of gender;
2. Meeting the diagnostic criteria for stage 4 CKM syndrome;
3. Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;
4. Signed informed consent form.
Exclusion Criteria
1. Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;
2. Severe hepatic dysfunction (Child-Pugh class C);
3. History of recurrent urogenital tract infections;
4. History of allergy or intolerance to SGLT2 inhibitors;
5. Pregnant or lactating women;
6. Systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 60 mmHg;
7. Severe chronic kidney disease (eGFR \< 30 mL/min/1.73 m²);
8. Participation in other interventional clinical trials;
9. Other conditions deemed inappropriate for enrolment by the investigator(s).
Source: ClinicalTrials.gov (NCT07351643). StuddyBuddy aggregates publicly available trial information.