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

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 2

Conditions: ST Elevation Myocardial Infarction; Hyperlipidemias; Physiological Effects of Drugs; Dyslipidemias; Acute Coronary Syndrome; Hypercholesterolemia

Treatments: Drug: Alirocumab; Other: Sham Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03718286

EPIC.STEMI.2018

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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97 participants in 2 patient groups

Alirocumab

Experimental group

Treatment:

Drug: Alirocumab

Sham Control

Sham Comparator group

Treatment:

Other: Sham Control