NCT04974814

Effect of Statin Preloading in STEMI in Improving PCI Outcomes

Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.

Detailed description

Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis . Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths. Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD). Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI. Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations. The CTFC (corrected TIMI frame count) another approach to grade flow impairment, is an objective, quantitative, reproducible, and sensitive index for coronary blood flow\[9\]. TIMI flow may appear normal visually, but may correlate to abnormal CTFC. The CTFC has been proposed to have incremental prognostic accuracy in predicting survival outcome with reperfusion therapy . Higher CTFC values after PCI have also been found to be associated with poor clinical outcomes.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Rosuvastatin 40mg	patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
DRUG	Atorvastatin 80mg	patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
DRUG	Control Test	patients in control arm will not preloaded with statin in ER before PCI

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-10-01
• Completion: 2023-04-01
• First posted: 2021-07-23
• Last updated: 2022-07-21

Locations

1 site across 1 country: Egypt