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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02402400

Enrollment

Registered

2015-03-30

Start date

2015-07-31

Completion date

2016-03-31

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes, Non ST Elevation Myocardial Infarction

Keywords

NSTEMI

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.

Interventions

DRUGSub Lingual Ticagrelor

180mg sub-lingual ticagrelor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026