Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Ticagrelor

Criteria

Inclusion Criteria:

1. Patients presenting with ACS/NSTEMI

2. Informed, written consent

Exclusion Criteria:

1. Age < 18 years or Age > 90 years

2. Active bleeding; bleeding diathesis; coagulopathy

3. Increased risk of bradycardiac events

4. History of gastrointestinal or genitourinary bleeding <2 months

5. Major surgery in the last 6 weeks

6. History of intracranial bleeding or structural abnormalities

7. Suspected aortic dissection

8. 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)

9. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.

10. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows

11. Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l

12. Use of coumadin derivatives within the last 7 days

13. Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine

14. Known severe liver disease, severe renal failure

15. Known allergy to the study medications

16. Pregnancy

17. Human immunodeficiency virus treatment