*GOLDILOX-TIMI 69

  • Research type

    Research Study

  • Full title

    A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction, Persistent Inflammation, and Elevated N terminal Prohormone Brain Natriuretic Peptide

  • IRAS ID

    1003997

  • Contact name

    Anna Ravnefjord

  • Contact email

    anna.ravnefjord@astrazeneca.com

  • Sponsor organisation

    AstraZeneca AB

  • Eudract number

    2020-000840-75

  • Clinicaltrials.gov Identifier

    NCT04610892

  • Research summary

    The purpose of this study is to learn more about the effects that an experimental study drug called MEDI6570 can have on patients who have had a recent heart attack. This study will help us better understand heart disease in addition to seeing if MEDI6570 can help to reduce cholesterol blockages (atherosclerosis) in the blood vessels supplying blood to the heart.
    About 800 people will take part in this study and taking part is entirely voluntary. The study lasts for approximately 15 months and in this time period, participants will have 16 visits. Additional visits may be necessary if further follow-up is needed. The duration of each visit may be different in length, at most lasting a few hours.
    The study includes the following tests and procedures:
    • A full physical exam
    • Measurement of vital signs (blood pressure and heart rate), height and weight measurements
    • Blood and urine samples
    • An electrocardiogram (ECG) will measure the electrical activity of your heart
    • Computed tomography angiography (CTA) scan, which involves injecting a dye into the blood stream, to produce complete images of the blood vessels and tissues around your heart.
    • An echocardiogram will be performed using ultrasound to measure the heart’s function and size.
    • Two extra urine samples are optional in this study. These optional urine samples will be used to answer questions in future research.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    22/EE/0188

  • Date of REC Opinion

    5 Oct 2021

  • REC opinion

    Further Information Favourable Opinion