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 : Recruiting
First Posted : October 24, 2018
Last Update Posted : March 18, 2019
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)|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||September 15, 2019|
|Estimated Study Completion Date :||December 15, 2019|
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 ]
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
|Contact: Brandi Meeks, MScfirstname.lastname@example.org|
|Contact: Helen Nguyenemail@example.com|
|Hamilton Health Sciences, General Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Principal Investigator , MD|
|Principal Investigator:||Shamir Mehta, MD MSc FRCPC||Population Health Research Institute; McMaster University|