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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
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, sham-controlled parallel group clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab Drug: Alirocumab
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.




Primary Outcome Measures :
  1. Percent change in direct LDL cholesterol [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Percent change in Apo B [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Brandi Meeks, MSc 9055212100 epicstemi@phri.ca
Contact: Helen Nguyen 9055212100 epicstemi@phri.ca

Locations
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Canada, Ontario
Hamilton Health Sciences, General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Principal Investigator , MD         
Contact       epicstemi@phri.ca   
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Shamir Mehta, MD MSc FRCPC Population Health Research Institute; McMaster University

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03718286     History of Changes
Other Study ID Numbers: EPIC.STEMI.2018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs