assessment in patients with Type 2 diabetes mellitus in addition to cOronary artery disease after Percutaneous coronary intervention with regard to Sitagliptin-induced COronary plaque REgression (TOP-SCORE)
- Conditions
- Coronary artery disease with type 2 diabetes mellitus (T2DM)
- Registration Number
- JPRN-UMIN000017861
- Lead Sponsor
- Department of Cardiology, Fukuoka University School of Medicine
- Brief Summary
The addition of sitagliptin to statins did not cause coronary plaque regression in Type 2 diabetes mellitus with coronary artery disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) type 1 diabetes mellitus (2) patients who had experienced ketosis, diabetic coma and/or pre-coma within six months prior to providing consent (3) moderate to severe heart failure (New York Heart Association class 3 or 4, left ventricular ejection fraction <40%) (4) severe valvular heart disease (5) renal dysfunction (creatinine blood level of over 1.5 mg/dL in men and over 1.3 mg/dL in women) (6) familial hypercholesterolemia (7) contraindication to antiplatelet agent(8) history of chemical sensitivity to DPP4-I (9) pregnancy or lactation (10) severe infection, trauma or recent surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ominal change in percent atheroma volume (PAV) from baseline to 8-12 month`s follow-up determined by IVUS after Sitagliptin treatment IVUS
- Secondary Outcome Measures
Name Time Method (1) Percent change in total atheroma volume (TAV) determined by IVUS (2) Change in levels of low-density lipoprotein cholesterol, triglyceride, high-density lipoprotein cholesterol, hemoglobin A1c, blood sugar and blood pressure (3) Association between lipid profile and the change in PAV (4) Association between biomarker and the change in PAV