NCT07351643RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 25 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shenyang Northern Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07351643
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From 25 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;
Other illness
- History of recurrent urogenital tract infections;
- History of allergy or intolerance to SGLT2 inhibitors;
- Other conditions deemed inappropriate for enrolment by the investigator(s).
Lab values
- Severe chronic kidney disease (eGFR \< 30 mL/min/1.73 m²);
Other
- Severe hepatic dysfunction (Child-Pugh class C);
- Pregnant or lactating women;
- Systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 60 mmHg;
- Participation in other interventional clinical trials;
Who the study is looking for
- Aged ≥ 18 years, irrespective of gender;
- Meeting the diagnostic criteria for stage 4 CKM syndrome;
- Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;
- Signed informed consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.