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Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

Primary Purpose

Acute Coronary Syndromes, ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Chewing Ticagrelor
Oral Ticagrelor
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring STEMI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral Ticagrelor

Chewing Ticagrelor

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2016
Last Updated
January 9, 2017
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02725099
Brief Title
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
Official Title
Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes, ST Elevation Myocardial Infarction
Keywords
STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Ticagrelor
Arm Type
Active Comparator
Arm Title
Chewing Ticagrelor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chewing Ticagrelor
Intervention Description
180 mg Chewing Ticagrelor
Intervention Type
Drug
Intervention Name(s)
Oral Ticagrelor
Intervention Description
180 mg oral Ticagrelor
Primary Outcome Measure Information:
Title
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD
Time Frame
1, 4-6 hours
Title
Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
Time Frame
30 days
Title
Occurrence of dyspnea and/or symptomatic bradycardia
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting with STEMI Informed, written consent Exclusion Criteria: Age < 18 years or Age > 90 years Active bleeding; bleeding diathesis; coagulopathy Increased risk of bradycardic 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, unconsciousness, 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 The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days). If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.
Facility Information:
Facility Name
Sheba Medical center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
29071332
Citation
Asher E, Tal S, Mazin I, Abu-Much A, Sabbag A, Katz M, Regev E, Chernomordik F, Guetta V, Segev A, Elian D, Barbash I, Fefer P, Narodistky M, Beigel R, Matetzky S. Effect of Chewing vs Swallowing Ticagrelor on Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 Dec 1;2(12):1380-1384. doi: 10.1001/jamacardio.2017.3868.
Results Reference
derived

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Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

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