Ticagrelor Administered as Standard Tablet or Orodispersible Formulation

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero Universitaria di Sassari
• Collaborator: AstraZeneca
• Treatments: Ticagrelor

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