Early Alirocumab to Reduce LDL-C in Myocardial Infarction

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: Baim Institute for Clinical Research; Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium; Ezetimibe

Criteria

Inclusion Criteria:

• Males or females aged 18 years or above

• Admitted to hospital for ST-Segment Elevation MI (STEMI) or non-ST-Segment Elevation MI (NSTEMI) (proven by electrocardiogram (ECG) or biomarker evidence of MI)

• Statin naïve prior to MI

• Local LDL-C measurement available within 24 hrs of chest pain with no more than 1 dose of statin

• Ability and willingness to give written informed consent and to comply with the requirements of the study

Exclusion Criteria:

• No ECG or biomarker evidence of MI

• Received more than one dose of statin during the index event prior to randomisation

• Contraindication to atorvastatin 80mg

• Contraindication to ezetimibe

• Contraindication to alirocumab

• Unwillingness or inability to comply with study requirements, particularly with respect to laboratory tests, specifically blood draws 24 and 48 hours after randomisation, and subsequent clinic visits

• New York Heart Association (NYHA) Class IV Heart Failure

• Unstable arrhythmia

• Subjects who in the opinion of investigator have a life expectancy of < 9 weeks

• Women of child bearing age who are not using at least 2 methods of contraception

• Pregnant or breastfeeding.