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

NCT03718286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-04-11

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Shamir Mehta, MD MSc FRCPC · Population Health Research Institute; McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2021-06-30
Completion
2021-10-08

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718286 on ClinicalTrials.gov