Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI (EPIC STEMI)
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|ClinicalTrials.gov Identifier: NCT03718286|
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : April 11, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|ST Elevation Myocardial Infarction Acute Coronary Syndrome Hypercholesterolemia Hyperlipidemias Dyslipidemias Physiological Effects of Drugs||Drug: Alirocumab Other: Sham Control||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-blind, sham-controlled parallel group clinical trial.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||March 11, 2019|
|Actual Primary Completion Date :||June 30, 2021|
|Actual Study Completion Date :||October 8, 2021|
150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
|Sham Comparator: Sham Control||
Other: Sham Control
Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
- Percent change in direct LDL cholesterol [ Time Frame: 6 weeks ]
- Percent change in Apo B [ Time Frame: 6 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718286
|Hamilton Health Sciences, General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Shamir Mehta, MD MSc FRCPC||Population Health Research Institute; McMaster University|
|Responsible Party:||Population Health Research Institute|
|Other Study ID Numbers:||
|First Posted:||October 24, 2018 Key Record Dates|
|Last Update Posted:||April 11, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Lipid Metabolism Disorders