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

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02402400

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndromes Non ST Elevation Myocardial Infarction	Drug: Sub Lingual Ticagrelor	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Ticagrelor	Drug: Sub Lingual Ticagrelor 180mg sub-lingual ticagrelor
Experimental: Sub Lingual Ticagrelor	Drug: Sub Lingual Ticagrelor 180mg sub-lingual ticagrelor

Arm

Intervention/Treatment

Active Comparator: Oral Ticagrelor

Drug: Sub Lingual Ticagrelor

180mg sub-lingual ticagrelor

Experimental: Sub Lingual Ticagrelor

Drug: Sub Lingual Ticagrelor

180mg sub-lingual ticagrelor

Outcome Measures

Primary Outcome Measures

Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD [1hour]

Secondary Outcome Measures

The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD. [1, 4-6, 12 hours]
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events. [24 hours]
Occurrence of dyspnea and/or symptomatic bradycardia. [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients presenting with ACS/NSTEMI
Informed, written consent

Exclusion Criteria:

Age < 18 years or Age > 90 years
Active bleeding; bleeding diathesis; coagulopathy
Increased risk of bradycardiac events
History of gastrointestinal or genitourinary bleeding <2 months
Major surgery in the last 6 weeks
History of intracranial bleeding or structural abnormalities
Suspected aortic dissection
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)
Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l
Use of coumadin derivatives within the last 7 days
Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
Known severe liver disease, severe renal failure
Known allergy to the study medications
Pregnancy
Human immunodeficiency virus treatment