NCT07614230RecruitingPhase 4
SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes
Effects of SGLT2 Inhibitors on Coronary Atherosclerosis Progression in Diabetes Mediated by Perivascular Adipose Tissue: The SCOPE Trial
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
This study is a multicenter, randomized controlled trial to test whether an SGLT2 inhibitor (dapagliflozin), a type of diabetes medication, can slow down or even reverse the progression of coronary atherosclerosis (plaque buildup in the coronary arteries) in patients with type 2 diabetes. The effect may be mediated by improving the function of perivascular adipose tissue. A total of 144 adults with type 2 diabetes and stable coronary artery disease will be randomly assigned to receive either dapagliflozin plus standard diabetes and cardiovascular care (intervention group) or standard care alone (control group) for 18 months. Serial coronary CT angiography and other assessments will be performed to evaluate changes in coronary plaque volume, CT-derived fractional flow reserve, perivascular fat radiomics score, and various metabolic and inflammatory markers, to determine whether SGLT2 inhibition reduces cardiovascular risk.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Junjie Yang
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT07614230
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 144
- From 1 Jan 2026 to the primary completion date, 1 Jun 2027
- 2 sites 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- New York Heart Association (NYHA) functional class III or IV heart failure. Acute myocardial infarction within the previous 30 days.
Other illness
- History of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with stenting, prosthetic valve replacement, or permanent pacemaker implantation.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.
Lab values
- Known allergy to iodinated contrast media or other contraindications to CCTA. Severe arrhythmia or coronary artery calcium (CAC) score \>400.
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². History of serious adverse reactions to SGLT2 inhibitors.
Other
- Pregnancy, lactation, or planned pregnancy during the study period. Severe liver dysfunction (Child-Pugh class C).
Who the study is looking for
- Age between 18 and 75 years.
- Confirmed diagnosis of type 2 diabetes mellitus with SCORE2-Diabetes risk score \>10%.
- Stable angina pectoris.
- Coronary CT angiography (CCTA) demonstrating 50%-90% stenosis in at least one coronary vessel with diameter ≥2.5 mm.
- CT-derived fractional flow reserve (CT-FFR) \>0.8 in the target vessel.
- Stable standard therapy for diabetes and cardiovascular disease, with no changes in SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors within the past 4 weeks.
- Able and willing to provide written informed consent.
Age in the registry: 18 years to 78 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Sixth Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.