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

Sheba Medical Center

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndromes; Non ST Elevation Myocardial Infarction

Treatments: Drug: Sub Lingual Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02402400

SHEBA-15-2028-15-SMC-EA-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oral Ticagrelor

Active Comparator group

Treatment:

Drug: Sub Lingual Ticagrelor

Sub Lingual Ticagrelor

Experimental group

Treatment:

Drug: Sub Lingual Ticagrelor