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Alirocumab in Patients With Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02938949
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 19, 2016
Results First Submitted Date  ICMJE June 28, 2019
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
Changes in Low-density Lipoprotein (LDL) Cholesterol [ Time Frame: baseline and 14 days ]
Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14 [ Time Frame: baseline and 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Change in Inflammatory Markers (hsCRP) [ Time Frame: baseline to 3 days ]
    Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days
  • Change in Inflammatory Markers (hsCRP) [ Time Frame: baseline to 14 days ]
    Placebo-corrected Percentage Change in Inflammatory Markers (hsCRP) From Baseline to 14 Days
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days and 14 days [ Time Frame: baseline, 3 days and 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alirocumab in Patients With Acute Myocardial Infarction
Official Title  ICMJE Alirocumab in Patients With Acute Myocardial Infarction: A Randomized Controlled Double-Blinded Study
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Hypercholesterolemia
Intervention  ICMJE
  • Drug: alirocumab
    Other Name: Praluent
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: Alirocumab
    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.
    Intervention: Drug: alirocumab
  • Placebo Comparator: placebo
    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.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 16, 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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];
  2. 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.

Exclusion Criteria:

  1. Age <21 years of age
  2. Inability to give informed consent
  3. Previous, current or planned treatment with a PCSK9 inhibitor
  4. Known history of loss of function of PCSK9 (genetic mutation or sequence variation)
  5. Patient with homozygous familial hypercholesterolemia (clinically or by previous genotyping)
  6. 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);
  7. Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus);
  8. 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;
  9. Known chronic hepatitis B or C infection (excluding patients with a positive antibody who were successfully treated or who have demonstrated no viral load);
  10. Known human immunodeficiency virus infection.
  11. Use of fibrates other than fenofibrate within 6 weeks of the screening visit.
  12. 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.
  13. Known history of a hemorrhagic stroke.
  14. Has been previously treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in other clinical studies.
  15. Conditions/situations such as:

    1. 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.
    2. 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.

  16. 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;
  17. 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.
  18. Exclusion Criteria Related to the Current Knowledge of Alirocumab

    1. Known hypersensitivity to monoclonal antibody therapeutics
    2. Pregnant or breastfeeding women
  19. Women of childbearing potential who are not protected by highly effective method(s) of birth control throughout the entire duration of study treatment and for 10 weeks after the last dose of study drug and/or who are unwilling or unable to be tested for pregnancy.
  20. Men capable of impregnating women who are not protected by highly effective method(s) of birth control and/or who are unwilling to use an effective contraceptive method throughout the entire duration of study treatment and for 10 weeks after the last dose of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938949
Other Study ID Numbers  ICMJE HM20008008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE
  • Regeneron Pharmaceuticals
  • Sanofi
Investigators  ICMJE
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP