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

Acute Coronary Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02402400
• Other study ID #: SHEBA-15-2028-15-SMC-EA-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: March 25, 2015
• Last updated: November 22, 2015
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Sheba Medical Center
• Contact: Elad Asher, MD, MHA
• Phone: +972-52-6667131
• Email: EL.ASHER[@]GMAIL.COM
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction
• Syndrome

Intervention

Drug:
• Sub Lingual Ticagrelor
180mg sub-lingual ticagrelor

Locations

Country	Name	City	State
Israel	Sheba Medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD		1hour	No
Secondary	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	No
Secondary	Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.		24 hours	Yes
Secondary	Occurrence of dyspnea and/or symptomatic bradycardia.		24 hours	Yes