Alirocumab in Patients With Acute Myocardial Infarction

Completed · Phase 4 · Has a placebo group

Conditions studied: Myocardial Infarction, Hypercholesterolemia

In brief

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).

Key facts

Study ID

NCT02938949

Run by

Virginia Commonwealth University

People needed

20

Starts

2017-01-01

Expected to finish

2018-08-16

Last updated by the study team

2019-09-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute type I (spontaneous) NSTEMI defined as chest pain (or equivalent) with an onset of symptoms within 12 hours of presentation, a duration of >15 minutes, and elevated cardiac troponin I levels, with or without electrocardiographic changes [with the exclusion of ST elevation];
• 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:
• Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expectancy.
• Patients considered by the investigator or any sub-investigator to be inappropriate for this study for any reason:
• i. Those patients deemed unable to meet specific protocol requirements, such as scheduled visits.
• ii. Those patients the investigator deems unable to administer or tolerate long-term injections.
• c. Investigator or any sub-investigator, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of the protocol.
• d. Presence of any other conditions (geographic or social), actual or anticipated, that the investigator feels would restrict or limit the patient's participation for the duration of the study.
• Thyroid-stimulating hormone (TSH) < lower limit of normal (LLN) or > upper limit of normal (ULN); if TSH is abnormal due to controlled hypothyroidism (patient is on a stable dose of thyroid replacement therapy), the patient may be enrolled into the study;
• Exclusion Criteria Related to the Active Comparator and/or Mandatory Background Therapies: All contraindications to the background therapies or warnings/precautions of use (when appropriate) as displayed in the respective national product labeling.
• Exclusion Criteria Related to the Current Knowledge of Alirocumab
• Known hypersensitivity to monoclonal antibody therapeutics

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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