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

• ClinicalTrials.gov Identifier: NCT03718286
• Recruitment Status: Completed
• First Posted: October 24, 2018
• Last Update Posted: April 11, 2022
• Sponsor: Population Health Research Institute
• Information provided by (Responsible Party): Population Health Research Institute

Tracking Information

• First Submitted Date: October 23, 2018
• First Posted Date: October 24, 2018
• Last Update Posted Date: April 11, 2022
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 23, 2018): Percent change in direct LDL cholesterol [ Time Frame: 6 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 23, 2018): Percent change in Apo B [ Time Frame: 6 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

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

Condition

• ST Elevation Myocardial Infarction
• Acute Coronary Syndrome
• Hypercholesterolemia
• Hyperlipidemias
• Dyslipidemias
• Physiological Effects of Drugs

Intervention

• Drug: Alirocumab
  150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
• Other: Sham Control
  Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Study Arms

• Experimental: Alirocumab
  Intervention: Drug: Alirocumab
• Sham Comparator: Sham Control
  Intervention: Other: Sham Control

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2022): 97
• Original Estimated Enrollment (submitted: October 23, 2018): 100
• Actual Study Completion Date: October 8, 2021
• Actual Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03718286
• Other Study ID Numbers: EPIC.STEMI.2018
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Population Health Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Population Health Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shamir Mehta, MD MSc FRCPC; Population Health Research Institute; McMaster University

• PRS Account: Population Health Research Institute
• Verification Date: March 2022