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

March 19, 2016 updated by: Dr. Elad Asher, Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients presenting with ACS/NSTEMI
  2. Informed, written consent

Exclusion Criteria:

  1. Age < 18 years or Age > 90 years
  2. Active bleeding; bleeding diathesis; coagulopathy
  3. Increased risk of bradycardiac 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, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Ticagrelor
Drug: Sub Lingual Ticagrelor
180mg sub-lingual ticagrelor
Experimental: Sub Lingual Ticagrelor
Drug: Sub Lingual Ticagrelor
180mg sub-lingual ticagrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Time Frame: 1hour
1hour

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1, 4-6, 12 hours
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
Time Frame: 24 hours
24 hours
Occurrence of dyspnea and/or symptomatic bradycardia.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-15-2028-15-SMC-EA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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