The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx
研究概览
简要总结
Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, 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 dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
详细描述
Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
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,
- •not on any physician-prescribed medications or complementary/alternative therapies.
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
DAPA Tx
This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.
干预措施: DAPA Tx (Drug)
结局指标
主要结局
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx
时间窗: Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin
Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin
次要结局
未报告次要终点
研究者
Naveen Seecheran
Principal Investigator
The University of The West Indies