NCT03718286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

April 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

October 23, 2018

Last Update Submit

April 8, 2022

Conditions

ST Elevation Myocardial InfarctionAcute Coronary SyndromeHypercholesterolemiaHyperlipidemiasDyslipidemiasPhysiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

  • Percent change in direct LDL cholesterol

    6 weeks

Secondary Outcomes (1)

  • Percent change in Apo B

    6 weeks

Study Arms (2)

Alirocumab

EXPERIMENTAL
Drug: Alirocumab

Sham Control

SHAM COMPARATOR
Other: Sham Control

Interventions

AlirocumabDRUG

150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Alirocumab
Sham ControlOTHER

Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.

Sham Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences, General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36349701DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionAcute Coronary SyndromeHypercholesterolemiaHyperlipidemiasDyslipidemias

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shamir Mehta, MD MSc FRCPC

    Population Health Research Institute; McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized, double-blind, sham-controlled parallel group clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 24, 2018

Study Start

March 11, 2019

Primary Completion

June 30, 2021

Study Completion

October 8, 2021

Last Updated

April 11, 2022

Record last verified: 2022-03

Locations

CA(1)