Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
NCT ID: NCT02725099
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2016-05-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Ticagrelor
Oral Ticagrelor
180 mg oral Ticagrelor
Chewing Ticagrelor
Chewing Ticagrelor
180 mg Chewing Ticagrelor
Interventions
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Chewing Ticagrelor
180 mg Chewing Ticagrelor
Oral Ticagrelor
180 mg oral Ticagrelor
Eligibility Criteria
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Inclusion Criteria
2. Informed, written consent
Exclusion Criteria
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.
18 Years
90 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Elad Asher
MD
Locations
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Sheba Medical center
Ramat Gan, , Israel
Countries
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References
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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.
Other Identifiers
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SHEBA-15-2824-EA-CTIL
Identifier Type: -
Identifier Source: org_study_id
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