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OpenTrials
Completed

NCT Number: NCT02402400

Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study

Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) 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 ACS/NSTEMI
  • Informed, written consent

Exclusion criteria

  • Age < 18 years or Age > 90 years
  • Active bleeding; bleeding diathesis; coagulopathy
  • Increased risk of bradycardiac 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, 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

Treatment and study plan

Sub Lingual Ticagrelor

Drug

180mg sub-lingual ticagrelor

Primary outcomes

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

    Time frame: 1hour

Secondary outcomes

  1. The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.

    Time frame: 1, 4-6, 12 hours

  2. Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.

    Time frame: 24 hours

  3. Occurrence of dyspnea and/or symptomatic bradycardia.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2015
Registry last updated
Mar 22, 2016

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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