Status:
WITHDRAWN
Early Alirocumab to Reduce LDL-C in Myocardial Infarction
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Regeneron Pharmaceuticals
Baim Institute for Clinical Research
Conditions:
Myocardial Infarction
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 greate...
Detailed Description
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 includ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03750760
Start Date
January 1 2020
End Date
December 1 2021
Last Update
June 13 2019
Active Locations (17)
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1
Royal Devon & Exeter Hospital
Exeter, Devon, United Kingdom, EX2 5DW
2
The Royal Bournemouth General Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
3
East Sussex Healthcare NHS Trust
Saint Leonards-on-Sea, East Sussex, United Kingdom, TN37 7PT
4
Basildon Hospital
Basildon, Essex, United Kingdom, SS16 5NL