Clinical trial NCT02402400: Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
Official title: Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Non ST Elevation Myocardial Infarction
Keywords: NSTEMI
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
timeFrame: 1hour
Secondary outcomes:
measure: The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.
timeFrame: 1, 4-6, 12 hours
measure: Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
timeFrame: 24 hours
measure: Occurrence of dyspnea and/or symptomatic bradycardia.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical center
Study officials:
References:
citation: Asher E, Frydman S, Katz M, Regev E, Sabbag A, Mazin I, Abu-Much A, Kukuy A, Mazo A, Erez A, Berkovitch A, Narodistky M, Barbash I, Segev A, Beigel R, Matetzky S. Chewing versus Swallowing Ticagrelor to Accelerate Platelet Inhibition in Acute Coronary Syndrome - the CHEERS study. For The PLATIS (Platelets and Thrombosis in Sheba) Study Group. Thromb Haemost. 2017 Apr 3;117(4):727-733. doi: 10.1160/TH16-09-0728. Epub 2017 Feb 2.