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Completed

NCT Number: NCT02725099

Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting with STEMI
  • Informed, written consent

Exclusion criteria

  • Age < 18 years or Age > 90 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.

Treatment and study plan

Chewing Ticagrelor

Drug

180 mg Chewing Ticagrelor

Oral Ticagrelor

Drug

180 mg oral Ticagrelor

Primary outcomes

  1. Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD

    Time frame: 1 hour

Secondary outcomes

  1. The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD

    Time frame: 1, 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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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