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

Primary Purpose

ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Alirocumab
Sham Control
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamilton Health Sciences, General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Alirocumab

Sham Control

Arm Description

Outcomes

Primary Outcome Measures

Percent change in direct LDL cholesterol

Secondary Outcome Measures

Percent change in Apo B

Full Information

First Posted
October 23, 2018
Last Updated
April 8, 2022
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03718286
Brief Title
Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI
Acronym
EPIC STEMI
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Physiological Effects of Drugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, sham-controlled parallel group clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alirocumab
Arm Type
Experimental
Arm Title
Sham Control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Intervention Description
150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
Intervention Type
Other
Intervention Name(s)
Sham Control
Intervention Description
Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
Primary Outcome Measure Information:
Title
Percent change in direct LDL cholesterol
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percent change in Apo B
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD MSc FRCPC
Organizational Affiliation
Population Health Research Institute; McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences, General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36349701
Citation
Mehta SR, Pare G, Lonn EM, Jolly SS, Natarajan MK, Pinilla-Echeverri N, Schwalm JD, Sheth TN, Sibbald M, Tsang M, Valettas N, Velianou JL, Lee SF, Ferdous T, Nauman S, Nguyen H, McCready T, McQueen MJ. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial. EuroIntervention. 2022 Dec 2;18(11):e888-e896. doi: 10.4244/EIJ-D-22-00735.
Results Reference
derived

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

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