Dapagliflozin for Coronary Inflammation in Stage 4 CKM Syndrome After ACS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with stage 4 CKM syndrome who have undergone PCI for acute coronary syndrome are randomized at 1 month post-PCI to receive either dapagliflozin 10 mg daily plus standard therapy or standard therapy alone for 6 months. Inflammation around the coronary arteries is measured noninvasively using the fat attenuation index (FAI) derived from coronary CT angiography, and changes in plaque progression are evaluated. The study aims to determine if dapagliflozin reduces coronary arterial inflammation and whether it modulates plaque progression compared with standard care. Primary outcomes focus on FAI changes; secondary outcomes include plaque trajectory and safety in this high-risk population.

Why it matters

Who can join: the full rules

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).

Where it's running

• General Hospital of Northern Theater Command
  Shenyang, Liaoning, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.