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)

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) - TOP-SCORE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017861

Enrollment

Registered

2015-07-01

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease with type 2 diabetes mellitus (T2DM)

Interventions

Interventions (sitagliptin group) The period of intervention: 8-12 months The dosage of Sitagliptin: 50-100mg/day Control (non-sitagliptin group)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) T2DM patients 30 years of age or older who needed percutaneous coronary intervention (PCI) (2) T2DM patients with a baseline hemoglobin A1c (National Glycohemoglobin Standardization Program) level of 6.2% to 9.9% (if taking any hypoglycemic agents) or 6.5% to 9.9% (if receiving no medical treatment) (3) Patients treated dyslipidemia according to Japan Atherosclerosis Society Guideline for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases 2007 or 2012 version (4) written consent for participation in the study

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Nominal change in percent atheroma volume (PAV) from baseline to 8-12 month`s follow-up determined by IVUS after Sitagliptin treatment IVUS	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactAtsushi Iwata

Fukuoka University School of Medicine Department of Cardiology

iwaiwa@fukuoka-u.ac.jp81-92-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026