Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Sponsor
Imperial College London
Study ID
NCT03750760
Phase
PHASE4
Status
Withdrawn

Conditions

  • Dyslipidemias
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody
  • Atorvastatin 80mg — DRUG
    3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)
  • Ezetimibe 10mg — DRUG
    Cholesterol absorption inhibitor

Study Details

The EARLY trial is a phase IV, investigator initiated, international, multicentre study that will investigate if early use of alirocumab 150mg plus atorvastatin 80mg (enhanced care) will have a greater effect than atorvastatin 80mg (standard care) on the reduction of LDL-C at 2-weeks after a myocardial infarction (MI), in patients who start treatment within 24 hours of symptom onset. A secondary goal is to assess the effects of enhanced care when compared to standard care which is either atorvastatin alone or atorvastatin plus ezetimibe, (the latter added at 4 weeks if LDL-C is ≥ 70mg/dL (1.8mmol/L), on the proportion of patients achieving an LDL-C goal of \< 50mg/dL (1.29 mmol/L) at 7 weeks after an MI.

Key Dates

Start date
Jan 31, 2020
Status verified
Jun 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Alirocumab (enhanced care)
    Alirocumab (150 mg) administered by subcutaneous injection, every two weeks for 7 weeks. Atorvastatin (80 mg), oral administration daily.
  • Active Comparator: Atorvastatin (standard care)
    Atorvastatin (80 mg), oral administration daily. Ezetimibe (10 mg), oral administration daily, from week 4 if LDL-C is ≥ 70 mg/dL (1.8mmol/L) at week 4.

Primary Outcome Measure

Percentage change in LDL-C in enhanced care group verses standard of care group at 2 weeks after randomisation [ Time Frame: 2 weeks from baseline ]

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