Comparison of anti-atheroslerotic effects between intensified multifactorial intervention and conventional therapy in patients with coronary artery disease and type 2 diabetes

JRCT ID: jRCTs031200359

Registered date:12/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronary artery disease with diabetes mellitus
• Date of first enrollment: 17/11/2021
• Target sample size: 312
• Study type: Interventional
• Intervention(s): 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 pressure, and lipid control (targets: HbA1c <7.0%, blood pressure <140/90 mmHg, LDL cholesterol <100 mg/dl for stable coronary artery disease or 70 mg/dl for acute coronary syndrome), or intensive therapy (HbA1c <6.2%, blood pressure <120/80 mmHg, LDL cholesterol <55 mg/dl) with predefined treatment steps.

Outcome(s)

• Primary Outcome: Absolute chagens in percent plaque volumes in non-target coronary lesions as assessed by IVUS from post-procedure to 18 months

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: Hibi Kiyoshi
• Secondary Sponsor: Sugano Teruyasu
• Source(s) of Monetary Support: Japan Society for the Promotion of Science