Acute Coronary Syndrome, Dyslipidemias, Hypercholesterolemia, Hyperlipidemias, Physiological Effects of Drugs, ST Elevation Myocardial Infarction
Conditions
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.
Interventions
DRUGAlirocumab
150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
OTHERSham Control
Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
A randomized, double-blind, sham-controlled parallel group clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in direct LDL cholesterol | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in Apo B | 6 weeks |
Countries
Canada
Outcome results
None listed