Clinical trial NCT03718286: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ST Elevation Myocardial Infarction
Acute Coronary Syndrome
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Physiological Effects of Drugs
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, sham-controlled parallel group clinical trial.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percent change in direct LDL cholesterol
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent change in Apo B
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute; McMaster University
name: Shamir Mehta, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.