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Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016611
Recruitment Status : Unknown
Verified January 2017 by Dr. Elad Asher, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Elad Asher, Sheba Medical Center

Brief Summary:
To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome STEMI Drug: Chewing Ticagrelor LD Drug: Chewing Prasugrel LD Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2017
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Chewing Ticagrelor Drug: Chewing Prasugrel LD
60 mg Chewing Prasugrel

Experimental: Chewing Prasugrel Drug: Chewing Ticagrelor LD
180 mg Chewing Ticagrelor




Primary Outcome Measures :
  1. Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. 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 ]
  2. Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events [ Time Frame: 30 days ]
  3. Occurrence of dyspnea and/or symptomatic bradycardia [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016611


Contacts
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Contact: Elad Asher, MD; MHA +972-52-6667131 el.asher@gmail.com

Locations
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Israel
Sheba Medical center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Dr. Elad Asher, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03016611    
Other Study ID Numbers: SHEBA-16-3634
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs