Asian Diabetes Outcomes Prevention Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event
研究概览
简要总结
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.
详细描述
Rationale:
Cardiovascular events are the leading cause of death among patients with diabetes. Early identification of high-risk diabetic (DM) patients for intensification of preventive therapy may prevent cardiovascular events.
Aims:
Among biomarker (N-terminal pro-B-type natriuretic peptide, NT-proBNP)-identified high-risk type 2 DM patients without pre-existing cardiovascular disease, to test if intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi], beta-blockade, sodium-glucose co-transporter 2 inhibitors [SGLT2i]) may be associated with reduced cardiovascular events compared to standard of care.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least six months
- •≥ 40 years of age, men or women
- •No known cardiovascular disease ( defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)
- •NT-proBNP > 125 pg/mL
- •Written informed consent
排除标准
- •History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance
- •Patients already on a maximum dose of RAASi or beta-blocker
- •History of DM ketoacidosis/Type 1 DM
- •eGFR < 45ml/min/1.73m2
- •Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) < 100mmHg.
- •Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and/or Visit 1 heart rate (HR) < 60bpm.
- •Any disease other than diabetes lowering the patient's life expectancy to less than two years.
- •Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease
- •Systemic treatment with corticosteroids.
- •Pregnant or nursing women
- •Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.
- •Participation in an investigational drug trial
研究组 & 干预措施
Intensive Treatment Group
High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.
干预措施: Renin-angiotensin-aldosterone system inhibitors (Drug)
Intensive Treatment Group
High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.
干预措施: Beta blocker (Drug)
Intensive Treatment Group
High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.
干预措施: SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product (Drug)
结局指标
主要结局
Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event
时间窗: 48 months
Stroke/myocardial infarction/heart failures events
次要结局
未报告次要终点