Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

NCT ID: NCT02725099

Last Updated: 2017-01-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Coronary Syndromes ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Ticagrelor

Group Type ACTIVE_COMPARATOR

Oral Ticagrelor

Intervention Type DRUG

180 mg oral Ticagrelor

Chewing Ticagrelor

Group Type EXPERIMENTAL

Chewing Ticagrelor

Intervention Type DRUG

180 mg Chewing Ticagrelor

Interventions

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Chewing Ticagrelor

180 mg Chewing Ticagrelor

Intervention Type DRUG

Oral Ticagrelor

180 mg oral Ticagrelor

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Elad Asher

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical center

Ramat Gan, , Israel

Site Status

Countries

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Israel

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.

Reference Type DERIVED
PMID: 29071332 (View on PubMed)

Other Identifiers

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SHEBA-15-2824-EA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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