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

Phase 4

Completed

• Conditions: Acute Coronary Syndromes; Non ST Elevation Myocardial Infarction
• Interventions: Drug: Sub Lingual Ticagrelor

• Registration Number: NCT02402400
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Study Start: 2015-07
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-19
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Ticagrelor	Sub Lingual Ticagrelor	-
Sub Lingual Ticagrelor	Sub Lingual Ticagrelor	-

Primary Outcome Measures

Name	Time	Method
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD	1hour

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sheba Medical center; 🇮🇱 Ramat Gan, Israel