Coronary artery disease with diabetes mellitus coronary artery disease, diabetes mellitus, dyslipidemia, hypertension
Conditions
Interventions
Patients with coronary artery disease and diabetes mellitus aged 20-74 years with hypertension, dyslipidaemia, or both were randomly assigned to receive conventional therapy for glucose, blood pressur
randomization, intensive treatment, standard treatments
Sponsors
Hibi Kiyoshi
Sugano Teruyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with coronary artery disease and diabetes mellitus who underwent sucessful PCI in the target lesions and had significant coronary plaques in non-target leisons
Exclusion criteria
Exclusion criteria: Patients with bypass graft, in-stent restenosis, lesions with previous PCI treatments, lesions with severe calcification, familial hypercholesterolemia, type 1 diabetes mellitus, insulin treatment, history of operation of gastrointestinal tracts, severe renal and/or liver dysfunction, severe cardiac dysfunction, cancer treatments, cerebrovascular disease within 3 months before the enrollment, treatments of infectious diseases or any operation within 3 months after the enrollment, treatments with immunosuppressants and prednisolone, active bleeding, allergy and/or adverse events to stduy drugs, asthma, or pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute chagens in percent plaque volumes in non-target coronary lesions as assessed by IVUS from post-procedure to 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percent chagens in percent plaque volumes in non-target coronary lesions as assessed by IVUS from post-procedure to 18 months - Changes in coronary tissue characteristics (percent lipid and fibrous volumes) from post-procedure to 18 months - Changes in risk factors (HbA1c, blood pressure, LDL-C, HDL-C, TG) and status of achivements of target goals of risk factors - Minimum lumen diameter and area, percent stenosis and lumen volumes of target lesions as assessed by IVUS and QCA - Associations of coronary plaque volumes and tissue characteristics of non-target lesions as well as lumen parameters of target lesions with changes in risk factors and status of achievements of target goals of risk factors - Safety profile (percentages of adverse events, and abnormalities of blood test: Cr, AST, ALT, CK, etc) - MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal cerebral infarction, unplanned revascularization) - Association between AT1 receptor-associated protein (ATRAP) and changes in plaque volume and tissue characteristics | — |
Contacts
Public ContactKozo Okada
Yokohama City University Medical Center
Outcome results
None listed