Bempedoic Acid in Primary Percutaneous Coronary Intervention: Impact on Inflammatory Markers, Procedural and Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- 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
Ahmed Mostafa Sayed Ahmed
Principal Investigator
Assiut University
