The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- P2Y12 Reaction Units
研究概览
简要总结
The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.
详细描述
Sodium GLucose Transport 2 inhibitors (SGLT2I), including empagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open-Label
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
- •between 18 and 74 years of age,
- •have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months,
排除标准
- •presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
- •history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
- •history of clinical and/or hemodynamic instability,
- •within 1 month of placement of a bare metal stent,
- •within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
- •planned coronary revascularization,
- •treatment with fibrin-specific fibrinolytic therapy <24 h or non-fibrin-specific fibrinolytic therapy <48 h,
- •use of an oral anticoagulation agent or international normalized ratio >1.5,
- •body weight <60 kg,
- •age >75 years,
- •hemoglobin <10 g/dL,
- •platelet count <100×106/μL,
- •creatinine >2 mg/dL,
- •hepatic enzymes >2.5 times the upper limit of normal,
- •pregnancy and/or lactation.
研究组 & 干预措施
SGLT2i
Empagliflozin 25 mg per oral once daily
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
P2Y12 Reaction Units
时间窗: 14 days
P2Y12 Reaction Units post-Empagliflozin. Citrated blood samples are processed by CRAs and study investigators. The platelet function assay to be utilized is the VerifyNow P2Y12 (VN-P2Y12) assay (Accriva, San Diego, California). In brief, the VN-P2Y12 assay is a rapid whole blood point-of-care device that reports results as P2Y12 reaction units (PRU) and percent inhibition of platelet aggregation (%IPA). Assays will be performed as per the instructions of the manufacturer previously described.
次要结局
未报告次要终点
研究者
Naveen Seecheran
Principal Investigator
The University of The West Indies