Alirocumab in Patients With Acute Myocardial Infarction

NCT02938949 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HM20008008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Infarction; Hypercholesterolemia

Keywords

Myocardial Infarction; Low Density Lipoprotein Cholesterol; proprotein convertase subtilisin kexin 9, human; alirocumab

Outcome Measures

Primary Outcomes (1)

• Changes in Low-density Lipoprotein (LDL) Cholesterol

  Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14

  baseline and 14 days

Secondary Outcomes (2)

• Change in Inflammatory Markers (hsCRP)

  baseline to 3 days

• Change in Inflammatory Markers (hsCRP)

  baseline to 14 days

Study Arms (2)

Alirocumab

ACTIVE COMPARATOR

Alirocumab (150 mg) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.

Drug: alirocumab

placebo

PLACEBO COMPARATOR

Placebo (sterile saline) will be administered by subcutaneous injection once, within the first day of the patient's diagnosis of NSTEMI. Patients will also receive an 80 mg dose of atorvastatin.

Drug: placebo

Interventions

alirocumab DRUG

Also known as: Praluent

Alirocumab

placebo DRUG

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On medical therapy with high intensity statin prior to admission (either atorvastatin 40-80 mg or rosuvastatin 20-40 mg) as documented by hospital or pharmacy records and with known LDL cholesterol ≥70 mg/dL within the prior 12 months.

You may not qualify if:

• Age \<21 years of age
• Inability to give informed consent
• Previous, current or planned treatment with a PCSK9 inhibitor
• Known history of loss of function of PCSK9 (genetic mutation or sequence variation)
• Patient with homozygous familial hypercholesterolemia (clinically or by previous genotyping)
• Recent (\<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids \[\>1mg/kg of prednisone equivalent\], Tumor Necrosis Factor-α blockers, cyclosporine) not including non-steroidal antinflammatory drugs or corticosteroids used for IV dye allergy or corticosteroids used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks prior to randomization (note: topical, intra-articular, nasal, inhaled, and ophthalmic steroid therapies are not considered "systemic" and are allowed);
• Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus);
• History of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer;
• Known chronic hepatitis B or C infection (excluding patients with a positive antibody who were successfully treated or who have demonstrated no viral load);
• Known human immunodeficiency virus infection.
• Use of fibrates other than fenofibrate within 6 weeks of the screening visit.
• Uncontrolled hypothyroidism. Note: patients on thyroid replacement therapy can be included if the dosage of thyroxin has been stable for at least 12 weeks prior to screening.
• Known history of a hemorrhagic stroke.
• Has been previously treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in other clinical studies.
• Conditions/situations such as:

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Hypercholesterolemia; Hypercholesterolemia, Autosomal Dominant, 3

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Cory Trankle, MD
• Organization: Virginia Commonwealth University

cory.trankle@vcuhealth.org

804-213-2679

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 19, 2016
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 16, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)