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Withdrawn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

First listed
Nov 23, 2018
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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