NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

Alirocumab in Patients With Acute Myocardial Infarction: A Randomized Controlled Double-Blinded Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to high-intensity statin (atorvastatin 80 mg) in lowering low density lipoprotein (LDL) cholesterol during non-ST segment elevation myocardial infarction (NSTEMI).

Detailed description

This research will study the effects of early initiation of alirocumab in addition to high intensity statin therapy in patients who have previously been treated with high intensity statins with poor response, who present with a type I (spontaneous) acute NSTEMI. Patients will be dosed with drug or placebo once during the first day of their hospital admission. Blood samples will be collected at baseline, 3 days and 14 days after randomization for biomarker testing. Particular attention will be paid to additional LDL lowering effects, as well as the effects on PCSK9 levels and inflammatory biomarkers. Safety and tolerability will be monitored with complete blood count + differential and complete metabolic panels at each study visit.

Conditions

• Myocardial Infarction
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	alirocumab
DRUG	placebo

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-01
• Completion: 2018-08-16
• First posted: 2016-10-19
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study