Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease

Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease - COMBO Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006890

Enrollment

Registered

2011-12-16

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

Diabetic Patients With Coronary Aretry Disease

Interventions

Nicorandil Group Non-Nicorandil Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive Diabetic Patients Undergoing Percutaneous Coronary Intervention to Non-LAD Lesions Who Deos Not Have Contraindication of Nicorandil

Exclusion criteria

Exclusion criteria: -Renal Dysfunction (Scr>=2.0) -Liver Dysfunction (AST, ALT>=3ULN -Hemodialysis Patients (HD, PD) -Allergic to Study Drug (Nicorandil) -Severe Illness -Lack Decision-Making Capacity

Design outcomes

Primary

Measure	Time frame
Parameter of microcirculatory dysfunction (hyperemic microvascular resistance: h-MRv) at index procedure and follow angiography	—

Secondary

Measure	Time frame
-Quantitative and qualitative analysis of carotid artery plaque using ultrasonography -Endo-PAT2000(Parameter of Endothelial Dysfunction) -ABI -UCG Findings (EF, LVDd, IVS/PW, LAD, E/e') -Lipid Profile (LDL-C, HDL-C, TG, FFA, RLP-C, Apo-AI, Apo-AII, ApoB, Apo-CII, Apo-CIII) -Abdominal US (fatty liver) -Abdominal Circumference -Inflammation Marker (hs-CRP) -Diabetic Status (IRI, FBS, adiponectin, 75g OGTT, HbA1c) -Labolatory Data (AST, ALT, LDH, CPK, Scr, e-GFR) -Adverse Events (Cardiac Death, Nonfatal MI, Unatable Angina, Revascularization, heart failure, stroke, New Coronary Lesion)	—

Measure

Time frame

-Quantitative and qualitative analysis of carotid artery plaque using ultrasonography -Endo-PAT2000(Parameter of Endothelial Dysfunction) -ABI -UCG Findings (EF, LVDd, IVS/PW, LAD, E/e') -Lipid Profile (LDL-C, HDL-C, TG, FFA, RLP-C, Apo-AI, Apo-AII, ApoB, Apo-CII, Apo-CIII) -Abdominal US (fatty liver) -Abdominal Circumference -Inflammation Marker (hs-CRP) -Diabetic Status (IRI, FBS, adiponectin, 75g OGTT, HbA1c) -Labolatory Data (AST, ALT, LDH, CPK, Scr, e-GFR) -Adverse Events (Cardiac Death, Nonfatal MI, Unatable Angina, Revascularization, heart failure, stroke, New Coronary Lesion)

—

Countries

Japan

Outcome results

None listed

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