Antiplatelet Therapy After Cardiac Arrest
Condition: Cardiac Arrest; Postresuscitation Syndrome; Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
MeSH terms: Myocardial Infarction; Heart Arrest; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Clopidogrel; Ticagrelor
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antiplatelet Therapy; Cardiac Arrest; Therapeutic hypothermia; Myocardial infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)

Summary:

      There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid
      (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after
      cardiac arrest as in normothermic patients. The reasons for this are probably slower
      gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take
      action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we
      expect its effect to be good even in patients with therapeutic hypothermia after cardiac
      arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous
      coronary intervention will be randomised into two groups. One will be treated with ASA and
      clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and
      2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be
      measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups
      will be analysed.

      Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with
      clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia
      and percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male over 18 years old

          -  Unconscious survivors of cardiac arrest treated with therapeutic hypothermia

          -  Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest

          -  PCI with stent implantation

          -  Provision of informed consent prior to any study specific procedures is impossible
             because subjects are unconscious at the moment of inclusion

        Exclusion Criteria:

          -  Use of any P2Y12 inhibitors in last 10 days

          -  Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor

          -  Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor

          -  Thrombocytopenia (<50*109/L)

          -  Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor

          -  Ticagrelor contraindications: previous intracranial bleeding, active pathological
             bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation

          -  Suspected or confirmed pregnancy

          -  Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor