Effect of Statin Preloading in STEMI in Improving PCI Outcomes

NCT04974814 | Unknown

• 1 other identifier: statin in STEMI
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

STEMI; statin; PCI

Outcome Measures

Primary Outcomes (2)

• 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'.

  3 months

• 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.

  3 months

Study Arms (3)

control group

PLACEBO COMPARATOR

in this group patients will not receive statin before primary PCI

Drug: Control Test

atorvastatin group

ACTIVE COMPARATOR

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

Drug: Atorvastatin 80mg

rosuvastatin group

ACTIVE COMPARATOR

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

Drug: Rosuvastatin 40mg

Interventions

Rosuvastatin 40mg DRUG

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

rosuvastatin group

Atorvastatin 80mg DRUG

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

atorvastatin group

Control Test DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

National Heart Institute

Cairo, 12651, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 32651772 RESULT

• 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.

  PMID: 24216317 RESULT

• 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.

  PMID: 31354240 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Esraa M Adel, bachelor

  National Heart Institute

  PRINCIPAL INVESTIGATOR

• Ahmed A El berry, phd

  Beni-Suef University

  STUDY DIRECTOR

• Raghda R Hussein, phd

  Beni-Suef University

  STUDY DIRECTOR

• Ahmed A Abd el hamid

  National Heart Institute

  STUDY DIRECTOR

Central Study Contacts

Esraa M Adel, bachelor

CONTACT

01026 028251; esso_935@hotmail.com

Raghda R Hussein, phd

CONTACT

01010647666; raghda.hussien@pharm.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The clinical study will be a prospective open label randomized controlled trial

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 23, 2021
• Study Start: May 26, 2021
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)