Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI

Acute Coronary Syndrome Clinical Trial

— EPIC STEMI  

Official title:

Effects of Acute, Rapid Lowering of Low Density Lipoprotein Cholesterol With Alirocumab in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718286
• Other study ID #: EPIC.STEMI.2018
• Status: Completed
• Phase: Phase 2
• Start date: March 11, 2019
• Est. completion date: October 8, 2021

Study information

• Verified date: March 2022
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a PCSK9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (LDL) in 100 high-risk patients presenting with STEMI and referred for primary PCI. The objective is to determine the effect of acute, rapid lowering of LDL cholesterol with alirocumab added to high dose statin therapy in patients with STEMI undergoing primary PCI. The hypothesis is that, in patients with STEMI undergoing primary PCI, rapid lowering of LDL cholesterol with a PCSK9 Inhibitor (alirocumab) initiated in the acute setting pre-PCI, will favourably affect LDL cholesterol concentrations compared with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 8, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting with STEMI defined as both of the following: a) Symptoms of myocardial ischemia lasting for = 30 minutes, and b) Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads.
• Referred for primary PCI for presenting symptoms.
• Randomized within 12 hours of symptom onset and prior to diagnostic angiography.

Exclusion Criteria:

• Age =18 years.
• Pregnancy or breastfeeding.
• Current or planned treatment with a PCSK9 inhibitor.
• Allergy or contra-indication to a PCSK9 inhibitor.
• Killip class =2.
• Known Creatinine clearance <30mL/min.
• Suspected takotsubo / stress-induced cardiomyopathy or acute pericarditis.
• Any other medical, geographic, or social factor making study participation impractical or precluding follow-up.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias
• Infarction
• Myocardial Infarction
• Physiological Effects of Drugs
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Alirocumab
150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Other:
• Sham Control
Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in direct LDL cholesterol		6 weeks
Secondary	Percent change in Apo B		6 weeks