Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
Primary Purpose
Acute Coronary Syndromes, Non ST Elevation Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Sub Lingual Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring NSTEMI
Eligibility Criteria
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
Sites / Locations
- Sheba Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oral Ticagrelor
Sub Lingual Ticagrelor
Arm Description
Outcomes
Primary Outcome Measures
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Secondary Outcome Measures
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
Occurrence of dyspnea and/or symptomatic bradycardia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02402400
Brief Title
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
Official Title
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes, Non ST Elevation Myocardial Infarction
Keywords
NSTEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Ticagrelor
Arm Type
Active Comparator
Arm Title
Sub Lingual Ticagrelor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sub Lingual Ticagrelor
Intervention Description
180mg sub-lingual ticagrelor
Primary Outcome Measure Information:
Title
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Time Frame
1hour
Secondary Outcome Measure Information:
Title
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
Title
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
Time Frame
24 hours
Title
Occurrence of dyspnea and/or symptomatic bradycardia.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
28150850
Citation
Asher E, Frydman S, Katz M, Regev E, Sabbag A, Mazin I, Abu-Much A, Kukuy A, Mazo A, Erez A, Berkovitch A, Narodistky M, Barbash I, Segev A, Beigel R, Matetzky S. Chewing versus Swallowing Ticagrelor to Accelerate Platelet Inhibition in Acute Coronary Syndrome - the CHEERS study. For The PLATIS (Platelets and Thrombosis in Sheba) Study Group. Thromb Haemost. 2017 Apr 3;117(4):727-733. doi: 10.1160/TH16-09-0728. Epub 2017 Feb 2.
Results Reference
derived
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Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
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