Ticagrelor Administered as Standard Tablet or Orodispersible Formulation
Condition: ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation MI
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Ticagrelor orodispersible tablets; Ticagrelor standard tablets
Intervention description: Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.; Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
Intervention MeSH terms: Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of platelet inhibition at different timepoints between 65 patients in the treatment arm (receiving orodispersible formulation of ticagrelor loading dose) versus 65 patients in the control arm (receiving standard coated formulation of ticagrelor loading dose). Randomization will be further stratified according to morphine use.
Masking: Single (Investigator)
Masking description: Site investigators performing platelet function tests will be blinded regarding patient randomization arm and the blood samples will be fully anonymized.
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized clinical study evaluating superiority in platelet inhibition after administration
      of Ticagrelor 180 mg loading dose as an orodispersible formulation versus traditional coated
      tablets in patients admitted for ST elevation myocardial infarction or very high-risk non-ST
      elevation myocardial infarction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients presenting within 12 hours from the onset of symptoms with STEMI or very
             high-risk NSTEMI referred for immediate (< 2 hours) angiography. Very high-risk NSTEMI
             patients include patients with haemodynamic instability or cardiogenic shock, heart
             failure, life-threatening arrhythmias or resuscitated cardiac arrest, intermittent
             ST-segment elevation, or ongoing chest pain.

          2. Informed, written consent

          3. Male or female patients, aged ≥ 18 years old

        Exclusion Criteria:

          1. Age < 18 years

          2. Active bleeding; bleeding diathesis; coagulopathy

          3. History of gastrointestinal or genitourinary bleeding <2 months

          4. Major surgery in the last 6 weeks

          5. History of intracranial bleeding or structural abnormalities

          6. Suspected aortic dissection

          7. Administration in the week before the index event of clopidogrel, ticlopidine,
             prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or
             fondaparinux.

          8. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers,
             CYP3A with narrow therapeutic window

          9. Known relevant hematological deviations: Hb <10 g/dl, Thromb. <100x10^9/l

         10. Use of warfarin or new oral anticoagulant derivatives within the last 7 days

         11. Known severe liver disease, severe renal failure

         12. Allergy or hypersensitivity to ticagrelor or any of the excipients.

         13. Pregnancy or lactation