Effect of Upstream Treatment With High Intensity Statin on the Outcomes of STMI Patients Treated With PPCI

NCT04754789 | Unknown Phase 3 FDA Drug

• 1 other identifier: High dose statin pre PPCI
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effect of upstream treatment with high intensity statin on the outcome of ST segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention

Conditions

ST Elevation Myocardial Infarction

Keywords

PPCI

Outcome Measures

Primary Outcomes (3)

• laboratory investigation

  Follow up the change in inflammatory marker: C reactive protein during hospital admission, after 24 hours, 1 month then after 3 months

  up to 3 months after primary PCI

• laboratory investigation

  Follow up the change in inflammatory marker: Neutrophil lymphocyte ratio during hospital admission, after 24 hours, 1 month then after 3 months

  up to 3 months after primary PCI

• laboratory investigation

  Follow up the change in inflammatory marker: total leukocytic count during hospital admission, after 24 hours, 1 month then after 3 months

  up to 3 months after primary PCI

Secondary Outcomes (4)

• TIMI flow during PCI

  During primary PCI

• corrected TIMI frame count

  During primary PCI

• Myocardial blush grade during PCI

  During primary PCI

• MACE within 1 month and 3 months after primary PCI

  up to 3 months after primary PCI

Study Arms (2)

group for loading with statin before PPCI

ACTIVE COMPARATOR

All patients will receive the routine guidelines advised management before and after primary PCI. Patients will be randomly assigned (1:1) to receive two 80-mg loading doses of atorvastatin, the first loading dose will be administered in the Emergency Room before transfer to Cath Lab, the second dose of 80-mg atorvastatin will be administered 24 hours afterthe first dose.

Drug: Atorvastatin

group receive the routine guidelines management before PPCI

PLACEBO COMPARATOR

All patients will receive the routine guidelines advised management before and after primary PCI. Patients will be randomly assigned (1:1) to receive only the routine management.

Drug: Aspirin

Interventions

Atorvastatin DRUG

preloading with high dose statins (atorvastatin 80mg) with loading dose of dual antiplatelet( asprine 300 mg and ticagrelor 180 mg) pre-primary PCI

Also known as: aspirin, ticagrelor

group for loading with statin before PPCI

Aspirin DRUG

Loading dose of dual antiplatelet (asprine 300 mg and ticagrelor 180 mg)

Also known as: ticagrelor

group receive the routine guidelines management before PPCI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI patients eligible for primary PCI presented to Assiut university heart hospital.

You may not qualify if:

• Previous (within 3 months) or current treatment with statins
• Patients with contraindications to statins.
• Patients with cardiogenic shock.
• Patients with acute STEMI not eligible for Primary.
• Patients with other factors affecting leucocytic count such as active infection or leukemia.
• Inability to provide informed consent

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Atorvastatin; Aspirin; Ticagrelor

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Nagwa Ahmed Abdelrahman, Lecturer

  Nagwaabdelrahman@yahoo.com

  STUDY DIRECTOR

Central Study Contacts

Monica Nabil Attalla, resident

CONTACT

0122929123; monikanabil94@gmail.com

Yehia Taha Kishk, professor

CONTACT

01223971269; ytkishk2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: To assess the impact of treatment preloading with high dose statins (atorvastatin 80mg) pre-primary PCI on: The inflammatory markers (TLC, NLR, CRP), TIMI flow (corrected TIMI frame count), Myocardial blush ST resolution at 90 min after PCI, Major adverse cardiovascular events (MACE) (in-hospital, 30 days, 3months), (Cardiac mortality, MI, HF, stroke, revascularization, stent thrombosis).

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: February 15, 2021
• Study Start: February 20, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02