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Clinical Trials/NCT07129850
NCT07129850Not yet recruitingNot Applicable

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

Assiut University0 sites100 target enrollmentStarted: August 14, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
Change in inflammatory markers

Study Overview

Brief Summary

Bempedoic acid in PPCI

Detailed Description

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age ≥18 years STEMI diagnosis Undergoing primary PCI

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in inflammatory markers

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mostafa Sayed Ahmed

Principal Investigator

Assiut University

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