Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

ST Elevation Myocardial Infarction Clinical Trial

Official title:

Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725099
• Other study ID #: SHEBA-15-2824-EA-CTIL
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2016
• Last updated: January 9, 2017
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients presenting with STEMI

2. Informed, written consent

Exclusion Criteria:

1. Age < 18 years or Age > 90 years

2. Active bleeding; bleeding diathesis; coagulopathy

3. Increased risk of bradycardic 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, unconsciousness, 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

18. The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days).

19. If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.

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
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Chewing Ticagrelor
180 mg Chewing Ticagrelor
• Oral Ticagrelor
180 mg oral 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		1 hour	No
Secondary	The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD		1, 4-6 hours	No
Secondary	Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events		30 days	No
Secondary	Occurrence of dyspnea and/or symptomatic bradycardia		30 days	No