A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
Condition: Myocardial Infarction; Segment Elevation Myocardial Infarction (STEMI)
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Ticagrelor; Placebo
Intervention description: Oral Ticagrelor loading dose (180 mg) followed by matching placebo; Placebo followed by oral Ticagrelor loading dose (180 mg)
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1875.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart attack; heart disease; cardiovascular disease; stroke; reperfusion; pre hospital settings; ticagrelor; Percutaneous Coronary Intervention

Summary:

      The aim of this study is to determine whether initiation of ticagrelor as early as in the
      ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore
      facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the
      patient.

      The study will assess the efficacy and safety of pre-hospital compared to in-hospital
      administration of ticagrelor in co-administration with aspirin, on restoring the blood flow
      in the occluded heart artery and improving the myocardial perfusion in patients suffering
      from myocardial infarction and planned to have a PCI. Patients can be randomised in either
      one of the 2 arms:

      re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the
      pre-hospital administration and placebo for in-hospital administration.

      or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital
      administration and 180 mg ticagrelor loading dose for in-hospital administration.

      Patients are initially managed by ambulance physician/personnel in pre hospital settings.
      They are then transferred into a Catheterization room to undergo a PCI.

      After the administration of the loading dose of ticagrelor (double blind), patients will
      continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women must not be of child-bearing potential (1 year post-menopausal or surgically
             sterile).

          -  Symptoms of acute MI of more than 30 min but less than 6 hours

          -  New persistent ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram
             (ECG) leads.

        Exclusion Criteria:

          -  Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is
             more than 120 minutes

          -  Contraindication to ticagrelor (refer to SmPC)

          -  Concomitant medication that may increase the risk of bleeding [e.g non steroidal
             anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned
             or administered 24 hours before randomization]

          -  Any of the following conditions in the absence of a functioning implanted pacemaker:
             known SSS, second or third degree AVB, or documented syncope of suspected bradycardic
             origin.