Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study | NCT03016611 | Trialant
Unknown statusInterventionalPhase 4Updated Jan 10, 2017
Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study
ClinicalTrials.gov ID
NCT03016611
Lead Sponsor
Sheba Medical CenterOTHER_GOV
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 4
Enrollment
100Estimated
Last Update Posted
Jan 10, 2017Estimated
Start Date
Feb 2017
Primary Completion Date
Dec 2017Estimated
Brief Summary
To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Acute Coronary Syndrome
STEMI
Chewing Ticagrelor LD
Chewing Prasugrel LD
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with STEMI
Informed, written consent
Exclusion Criteria:
Age < 18 years or Age > 75 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.