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Early Alirocumab to Reduce LDL-C in Myocardial Infarction

NCT03750760 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-06-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alirocumab

PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody

DRUG

Atorvastatin 80mg

3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)

DRUG

Ezetimibe 10mg

Cholesterol absorption inhibitor

Sponsors & Collaborators

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Kausik Ray, Professor · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750760 on ClinicalTrials.gov