Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
Condition: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent
MeSH terms: Acute Coronary Syndrome
Intervention: Ticagrelor mashed pills; Ticagrelor integral pills
Intervention description: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient.; The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor).
Intervention MeSH terms: Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ticagrelor; antiplatelet; Acute Coronary Syndrome

Summary:

      The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the
      superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill
      both orally administrated in decreasing residual platelet reactivity 1 hour after the
      administration among 70 patients with STEMI (ST segment elevation myocardial infarction)
      undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting within 12 hours from the onset of symptoms with STEMI

          -  Informed, written consent

        Exclusion Criteria:

          -  Age < 18 years or Age > 75 years

          -  Active bleeding; bleeding diathesis; coagulopathy

          -  Increased risk of bradycardiac events

          -  History of gastrointestinal or genitourinary bleeding <2 months

          -  Major surgery in the last 6 weeks

          -  History of intracranial bleeding or structural abnormalities

          -  Suspected aortic dissection

          -  Any other condition that may put the patient at risk or influence study results or
             investigator's opinion (severe hemodynamic instability, known malignancies or other
             comorbid conditions with life expectancy <1 year)

          -  Administration in the week before the index event of clopidogrel, ticlopidine,
             prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or
             fondaparinux .

          -  Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers,
             CYP3A with narrow therapeutic windows

          -  Known relevant hematological deviations: Hb <10 g/dl, Thrombi. <100x10^9/l

          -  Use of coumadin derivatives within the last 7 days

          -  Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine

          -  Known severe liver disease, severe renal failure

          -  Known allergy to the study medications

          -  Pregnancy