Early Alirocumab to Reduce LDL-C in Myocardial Infarction
Early Alirocumab to Reduce LDL-C in Myocardial Infarction
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.
Patients with Acute Coronary Syndrome (ACS), which includes myocardial infarction, are at
 high risk of recurrent ischaemic events (e.g. heart attacks), and death. The current standard
 treatment includes high dose statins to lower low-density lipoprotein cholesterol (LDL-C),
 also known as bad cholesterol, soon after admission. In some cases, following assessment
 after 1-3 months, administration of a second line cholesterol lowering therapy (ezetimibe)
 may be added if LDL-C levels remain high ≥ 70mg/dL (1.8mmol/L). Many guidelines advocate that
 following ACS high dose statins should be used as first line therapy. If LDL-C levels remain
 greater than 70mg/dL (1.8mmol/L) then additional add on therapy on statins could be
 considered for ACS patients.

 Consented patients meeting the eligibility criteria for the EARLY trial will be randomised to
 enhanced care or standard care within 24hrs of symptom onset for MI. Patients randomised to
 enhanced care will receive alirocumab 150 mg on randomisation and then every 2 weeks during a
 7-week treatment period. All patients will receive atorvastatin 80 mg. Patients randomised to
 standard care with an LDL-C level ≥ 70mg/dL (1.8mmol/L) at week 4 will receive ezetimibe 10
 mg, in addition to atorvastatin 80 mg for the remaining duration of the treatment period.

 All patients will be followed up for a two-week period after completing the 7-week treatment
 period (i.e. a total of 9 weeks to assess safety).
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.