Effect of Statin Preloading in STEMI in Improving PCI Outcomes

Sponsor

Beni-Suef University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04974814

Collaborator

(none)

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Drug: Rosuvastatin 40mg Drug: Atorvastatin 80mg Drug: Control Test	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The clinical study will be a prospective open label randomized controlled trialThe clinical study will be a prospective open label randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 26, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group in this group patients will not receive statin before primary PCI	Drug: Control Test patients in control arm will not preloaded with statin in ER before PCI
Active Comparator: atorvastatin group in this group patients will receive 80 mg atorvastatin single dose before primary PCI	Drug: Atorvastatin 80mg patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
Active Comparator: rosuvastatin group in this group patients will receive 40 mg rosuvastatin single dose before primary PCI	Drug: Rosuvastatin 40mg patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI

Arm

Intervention/Treatment

Placebo Comparator: control group

in this group patients will not receive statin before primary PCI

Drug: Control Test

patients in control arm will not preloaded with statin in ER before PCI

Active Comparator: atorvastatin group

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

Drug: Atorvastatin 80mg

patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI

Active Comparator: rosuvastatin group

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

Drug: Rosuvastatin 40mg

patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI

Outcome Measures

Primary Outcome Measures

angiographic parameters [3 months]
CTFC (corrected TIMI frame count) In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. A correction factor is required to compensate for the longer length of the left anterior descending artery (LAD) compared with the circumflex and right coronary arteries (the number of frames required for dye to traverse the LAD is divided by 1.7). The frame count number after adjustment for vessel length is given the term 'corrected TIMI frame count'.
STR (ST-segment resolution) (STR) [3 months]
ST-segment resolution (STR) was calculated as the sum of ST-segment elevation on initial ECG minus the sum of ST-segment elevation on the ECG at 90 min after PCI, divided by the sum of ST- segment elevation on initial ECG, and was expressed as a percentage . The complete early STR was defined as more than or equal to 70% STR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.