NCT03718286

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-06-30
• Completion: 2021-10-08
• First posted: 2018-10-24
• Last updated: 2022-04-11

Locations

1 site across 1 country: Canada