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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2021-10-08

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-blind, sham-controlled parallel group clinical trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Alirocumab

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Sham Control

Group Type SHAM_COMPARATOR

Sham Control

Intervention Type OTHER

Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Interventions

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Alirocumab

150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Intervention Type DRUG

Sham Control

Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No