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