drugset / Trial / NCT03750760

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

NCT03750760

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-01
Primary completion
2020-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alirocumab Monoclonal antibody 150 mg Subcutaneous
Comparator Atorvastatin Small molecule 80 mg Oral
Comparator Ezetimibe Unknown 10 mg Oral