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

Sponsor
Population Health Research Institute
Study ID
NCT03718286
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 11, 2019
Status verified
Mar 2022
Primary completion
Jun 30, 2021
Completion
Oct 8, 2021

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Alirocumab
  • Sham Comparator: Sham Control

Primary Outcome Measure

Percent change in direct LDL cholesterol [ Time Frame: 6 weeks ]

Related Studies