Effect of Statin Preloading in STEMI in Improving PCI Outcomes

Beni-Suef University

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Drug: Rosuvastatin 40mg; Drug: Atorvastatin 80mg; Drug: Control Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04974814

statin in STEMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The Presence of symptoms (<12h).
• ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
• Patients age 18 to 80 years.

Exclusion criteria

• Previous (within 3 months) or current treatment with statins.
• Known allergy to heparin, aspirin, clopidogrel, or abciximab.
• Active severe bleeding.
• Pregnancy.
• History of major surgery or trauma.
• Significant gastrointestinal or genitourinary bleeding (<6 weeks).
• History of cerebrovascular attack (within 2 years) or cerebrovascular attack with a significant residual neurological deficit.
• Cardiogenic shock with mechanical ventilation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

in this group patients will not receive statin before primary PCI

Treatment:

Drug: Control Test

atorvastatin group

Active Comparator group

Description:

in this group patients will receive 80 mg atorvastatin single dose before primary PCI

Treatment:

Drug: Atorvastatin 80mg

rosuvastatin group

Active Comparator group

Description:

in this group patients will receive 40 mg rosuvastatin single dose before primary PCI

Treatment:

Drug: Rosuvastatin 40mg