Skip to main content
OpenTrials
Completed

NCT Number: NCT03718286

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ST Elevation Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Infarction Ischemia Lipid Metabolism Disorders Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Physiological Effects of Drugs Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton Health Sciences, General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alirocumab

Drug

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

Sham control

Other

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

Primary outcomes

  1. Percent change in direct LDL cholesterol

    Time frame: 6 weeks

Secondary outcomes

  1. Percent change in Apo B

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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

Acronym: EPIC STEMI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2018
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.