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Effect of Statin Preloading in STEMI in Improving PCI Outcomes

Primary Purpose

ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rosuvastatin 40mg
Atorvastatin 80mg
Control Test
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring STEMI, statin, PCI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control group

atorvastatin group

rosuvastatin group

Arm Description

in this group patients will not receive statin before primary PCI

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

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

Outcomes

Primary Outcome Measures

angiographic parameters
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)
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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2021
Last Updated
July 19, 2022
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04974814
Brief Title
Effect of Statin Preloading in STEMI in Improving PCI Outcomes
Official Title
Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
STEMI, statin, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The clinical study will be a prospective open label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
in this group patients will not receive statin before primary PCI
Arm Title
atorvastatin group
Arm Type
Active Comparator
Arm Description
in this group patients will receive 80 mg atorvastatin single dose before primary PCI
Arm Title
rosuvastatin group
Arm Type
Active Comparator
Arm Description
in this group patients will receive 40 mg rosuvastatin single dose before primary PCI
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 40mg
Intervention Description
patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
Intervention Type
Drug
Intervention Name(s)
Control Test
Intervention Description
patients in control arm will not preloaded with statin in ER before PCI
Primary Outcome Measure Information:
Title
angiographic parameters
Description
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'.
Time Frame
3 months
Title
STR (ST-segment resolution) (STR)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa M Adel, bachelor
Phone
01026 028251
Email
esso_935@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raghda R Hussein, phd
Phone
01010647666
Email
raghda.hussien@pharm.bsu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esraa M Adel, bachelor
Organizational Affiliation
National Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed A El berry, phd
Organizational Affiliation
Beni-Suef University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raghda R Hussein, phd
Organizational Affiliation
Beni-Suef University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed A Abd el hamid
Organizational Affiliation
National Heart Institute
Official's Role
Study Director
Facility Information:
Facility Name
National Heart Institute
City
Cairo
ZIP/Postal Code
12651
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32651772
Citation
Elserafy AS, Farag NM, El Desoky AI, Eletriby KA. Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Egypt Heart J. 2020 Jul 10;72(1):40. doi: 10.1186/s43044-020-00074-0.
Results Reference
result
PubMed Identifier
24216317
Citation
Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.
Results Reference
result
PubMed Identifier
31354240
Citation
Ma M, Bu L, Shi L, Guo R, Yang B, Cao H, Luo L, Lu L. Effect of loading dose of atorvastatin therapy prior to percutaneous coronary intervention in patients with acute coronary syndrome: a meta-analysis of six randomized controlled trials. Drug Des Devel Ther. 2019 Apr 16;13:1233-1240. doi: 10.2147/DDDT.S196588. eCollection 2019.
Results Reference
result

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Effect of Statin Preloading in STEMI in Improving PCI Outcomes

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