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

RecruitingPhase 4Ages 18 Years - anyAllShenyang Northern Hospital
NCT07351643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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).
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What it tests

  • Dapagliflozin
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Where

1 site
General Hospital of Northern Theater Command
Shenyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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