NCT05948969Unknown不适用
Transform CV Risk in Diabetes
American College of Cardiology2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- New prescription of a SGLT2i and/or GLP-1RA
研究概览
简要总结
This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2D diagnosis in the medical record
- •ASCVD, defined as follows:
- •Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
- •Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
- •Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization
排除标准
- •Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
- •Currently receiving any SGLT2i or GLP-1RA
- •Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
- •Currently receiving comfort care or enrolled in hospice
- •Life expectancy <1 year
- •History of or plan for heart transplantation or ventricular assist device
- •Current or planned hemodialysis
- •Decompensated end stage liver disease
- •History of Fournier's Gangrene
- •Type 1 diabetes
- •Prior history of diabetic ketoacidosis
- •Pregnancy or active breastfeeding
- •History of Pancreatitis or pancreatic cancer
- •History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)
结局指标
主要结局
New prescription of a SGLT2i and/or GLP-1RA
时间窗: 9 months
Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)
次要结局
未报告次要终点
研究者
研究点 (2)
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