drugset / Trial / NCT03718286

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

NCT03718286

Phase 2 Completed 97 enrolled Population Health Research Institute
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody 150 mg Subcutaneous