drugset / Trial / NCT03750760
Early Alirocumab to Reduce LDL-C in Myocardial Infarction
Phase 4
Withdrawn
Imperial College London
Baim Institute for Clinical Research · collabRegeneron Pharmaceuticals · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alirocumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Atorvastatin | Small molecule | 80 mg | Oral |
| Comparator | Ezetimibe | Unknown | 10 mg | Oral |