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

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Alirocumab
* Other: Sham Control


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, sham-controlled parallel group clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alirocumab<br> | Drug: Alirocumab<br>* 150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.<br>|
| Sham Comparator: Sham Control<br> | Other: Sham Control<br>* Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in direct LDL cholesterol |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Apo B |  | 6 weeks |