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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03016611 |
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Date of registration:
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09/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study
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Scientific title:
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Date of first enrolment:
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February 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03016611 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Elad Asher, MD; MHA |
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Address:
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Telephone:
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+972-52-6667131 |
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Email:
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el.asher@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients presenting with STEMI
2. Informed, written consent
Exclusion Criteria:
1. Age < 18 years or Age > 75 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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STEMI
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Acute Coronary Syndrome
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Intervention(s)
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Drug: Chewing Prasugrel LD
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Drug: Chewing Ticagrelor LD
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Primary Outcome(s)
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Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Occurrence of dyspnea and/or symptomatic bradycardia
[Time Frame: 30 days]
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Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
[Time Frame: 30 days]
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The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after Ticagrelor/Prasugrel LD
[Time Frame: 4-6 hours]
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Secondary ID(s)
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SHEBA-16-3634
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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