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

Population Health Research Institute97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

ST Elevation Myocardial Infarction Acute Coronary Syndrome Hypercholesterolemia Hyperlipidemias

Interventions

AlirocumabDRUG

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

Sham ControlOTHER

Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percent change in direct LDL cholesterol

Time frame: 6 weeks

Secondary Outcomes

Percent change in Apo B