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临床试验/NCT07129850
NCT07129850尚未招募不适用

Bempedoic Acid in Primary Percutaneous Coronary Intervention: Impact on Inflammatory Markers, Procedural and Clinical Outcomes

Assiut University0 个研究点目标入组 100 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Change in inflammatory markers

研究概览

简要总结

Bempedoic acid in PPCI

详细描述

Cardiovascular disease persists as the predominant cause of global burden of mortality and morbidity worldwide(1).

The cholesterol hypothesis posits that elevated blood cholesterol levels constitute a significant risk factor for atherosclerotic cardiovascular disease (ASCVD) and reducing cholesterol levels will consequently lower the risk of ASCVD(2).

Treatments aimed at lowering lipid levels have demonstrated their effectiveness in decelerating the advancement of atherosclerotic disease(3). This finding further reinforces the pathophysiological connections between plasma lipids and the progression of CAD. Among non-lipid mechanisms involved in reducing CAD progression, lipid-lowering drugs have also been implicated in plaque stabilization, reduced inflammation, reversal of endothelial dysfunction, and decreased thrombogenicity(3).

It is widely accepted that the beneficial effects of statins on cardiovascular events are mainly linked to their cholesterol lowering properties. Nonetheless, statins also have a clear action in reducing systemic inflammation. The effect on hsCRP is proportionally similar to that on LDL-C(4).

It is known that an anti-inflammatory action contributes to the reduction of cardiovascular risk independently of the effect on LDL-C. Four-year therapy with canakinumab, a specific anti-interleukin-1b monoclonal antibody, in patients with previous myocardial infarction reduced the relative risk of relapse by approximately 15% by reducing hsCRP levels by 60% without modifying LDL-C(5). It is therefore possible to hypothesize that cholesterol lowering drugs with an effect on hsCRP, such as statins and bempedoic acid, have advantages in reducing cardiovascular events compared to those that do not act on inflammation, such as PCSK9 inhibitors(4).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years STEMI diagnosis Undergoing primary PCI

排除标准

  • Known allergy to Bempedoic acid Active infection or chronic inflammatory disease Severe hepatic or renal dysfunction Use of immunosuppressive therapy

结局指标

主要结局

Change in inflammatory markers

时间窗: At 1 month post-PCI.

reactive protein \[CRP\] and tumor necrosis factor-alpha \[TNF-α\]) at 1 month post-primary PCI compared between the intervention group (Bempedoic Acid) and the control group.

次要结局

  • Final TIMI flow grade post-PCI.(1 day)
  • Major Adverse Cardiac Events(Within 30 days post-PCI.)
  • Lipid Profile Changes(At 1 month post-PCI.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mostafa Sayed Ahmed

Principal Investigator

Assiut University

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