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The DAPA-MI Study

  • Research type

    Research Study

  • Full title

    A Registry-based, Randomised, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Heart Failure or Cardiovascular Death in Patients without Diabetes with Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure

  • IRAS ID

    284188

  • Contact name

    Niklas Berglind

  • Contact email

    Niklas.Berglind@astrazeneca.com

  • Sponsor organisation

    Astra Zeneca AB

  • Eudract number

    2020-000664-31

  • Duration of Study in the UK

    2 years, 6 months, 2 days

  • Research summary

    This study will evaluate the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction, for the prevention of hospitalisation for heart failure or CV death.
    The study is conducted in Sweden and in the United Kingdom and will randomize about 6400 patients.
    The study will utilize 2 high-quality national, population-based clinical registries.
    The study is to start in the 3Q/4Q 2020 and is expected to end in the Q1/Q2 2023. This study is event driven. The anticipated duration of the study is approximately 30 months with an estimated median follow-up period for a patient of 21 months.

  • REC name

    North West - Haydock Research Ethics Committee

  • REC reference

    20/NW/0312

  • Date of REC Opinion

    23 Jul 2020

  • REC opinion

    Further Information Favourable Opinion