Ticagrelor and Clopdogrel on IMR

  • Research type

    Research Study

  • Full title

    A Randomised Mechanistic Study Comparing the Effects of Different Anti-platelet Combinations (Ticagrelor vs. Placebo/ Clopidogrel) with Aspirin in Patients presenting with Anterior STEMI Treated with Primary PCI.

  • IRAS ID

    139576

  • Contact name

    Stephen Hoole

  • Contact email

    s.hoole@nhs.net

  • Sponsor organisation

    Papworth Hospital NHS Foundation Trust

  • Eudract number

    2014-001277-14

  • Duration of Study in the UK

    3 years, 5 months, 31 days

  • Research summary

    For patients with acute onset anterior ST-elevation myocardial infarction (STEMI) the most effective treatment is primary percutaneous coronary intervention (PPCI) with the aim of unblocking coronary arteries, restoring myocardial blood flow, and limiting damage to heart muscle. Down stream of the main blockage in the large coronary arteries are the smaller myocardial microvascular vessels. Clinical outcomes in patients suffering STEMI are directly correlated to the integrity of these microvascular vessels. Maintenance of patency of these small vessels limits the size of a heart attack. In order to mitigate against myocardial damage during STEMI, patients are given antiplatelet therapy by paramedic staff enroute to their heart attack centre. The most routinely used antiplatelet agent is currently Clopidogrel. However, Ticagrelor is now a NICE (National Institute for Clinical Excellence) approved antiplatelet therapy for STEMI treatment and is gaining more clinical use.
    Ticagrelor is a potent and rapidly acting antiplatelet agent that benefits patients presenting with acute coronary syndromes. However, a recently published study has suggested that the onset of Ticagrelor antiplatelet action may be delayed in STEMI patients, suggesting an alternative mechanism for the early benefit of Ticagrelor in this specific patient group.
    To date, investigator brochures for Ticagrelor have detailed breathlessness and asymptomatic pauses in heart rhythm observed as side effects in patients in the initial phase of treatment with Ticagrelor and this has been attributed to adenosine. This has led to the hypothesis that the rapidly acting cardioprotective effect of Ticagrelor is one that may be adenosine mediated.
    This study sets out to explore whether the early benefit of Ticagrelor, in addition to it’s established antiplatelet action, is co-mediated by adenosine in maintaining and/or improving myocardial microcirculatory function.

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    15/EE/0032

  • Date of REC Opinion

    12 May 2015

  • REC opinion

    Further Information Favourable Opinion