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

Phase 2

Completed

• Conditions: ST Elevation Myocardial Infarction; Acute Coronary Syndrome; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Physiological Effects of Drugs
• Interventions: Other: Sham Control; Drug: Alirocumab

• Registration Number: NCT03718286
• Lead Sponsor: Population Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-03-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control	Sham Control	-
Alirocumab	Alirocumab	-

Primary Outcome Measures

Name	Time	Method
Percent change in direct LDL cholesterol	6 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change in Apo B	6 weeks

Trial Locations

Locations (1)

Hamilton Health Sciences, General Hospital; 🇨🇦 Hamilton, Ontario, Canada