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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03718286
Other study ID # EPIC.STEMI.2018
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 11, 2019
Est. completion date October 8, 2021

Study information

Verified date March 2022
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date October 8, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


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.

Locations

Country Name City State
Canada Hamilton Health Sciences, General Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change in direct LDL cholesterol 6 weeks
Secondary Percent change in Apo B 6 weeks
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