Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
研究概览
简要总结
Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.
详细描述
This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess
- the effect of evolocumab therapy on platelet activation and reactivity;
- the effect of evolocumab on biomarkers of platelet activation and inflammation.
Eligible patients will be randomized prior to start the PCI equally to either:
- 420 mg evolocumab ; or
- placebo. The randomized treatment will be administered in subcutaneous injections.
The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus
- •Dyslipidemia
- •Undergoing elective PCI
排除标准
- •Patients with recent Acute Coronary Syndrome (≤1 month)
- •Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel
- •Patients undergoing urgent/emergent PCI for stent thrombosis
- •Severe acute or chronic medical or psychiatric condition
- •Pregnancy
- •Participation in another experimental clinical trial, without formal approval
- •Unwillingness or inability to comply with the requirements of this protocol
研究组 & 干预措施
evolocumab 420mg
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
干预措施: Evolocumab (Drug)
placebo
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
时间窗: Baseline and after 30 days of treatment
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
次要结局
- Change in ADP-unstimulated P-selectin Expression(Baseline and after 30 days of treatment)
- Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)(Baseline and after 30 days of treatment)
- Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI(Baseline and after 30 days of treatment)