- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725099
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
January 9, 2017 updated by: Dr. Elad Asher, Sheba Medical Center
Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Study Overview
Status
Completed
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
-
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Ramat Gan, Israel
- Sheba Medical Center
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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:
- 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.
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
|
180 mg oral Ticagrelor
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Experimental: Chewing Ticagrelor
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180 mg Chewing Ticagrelor
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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: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
Time Frame: 30 days
|
30 days
|
Occurrence of dyspnea and/or symptomatic bradycardia
Time Frame: 30 days
|
30 days
|
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
|
1, 4-6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
May 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
March 27, 2016
First Submitted That Met QC Criteria
March 27, 2016
First Posted (Estimate)
March 31, 2016
Study Record Updates
Last Update Posted (Estimate)
January 10, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- SHEBA-15-2824-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.
Clinical Trials on ST Elevation Myocardial Infarction
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Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
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Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
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University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
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University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
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Inha University HospitalCompletedST Segment Elevation Myocardial Infarction | Non-ST Segment Elevation Myocardial InfarctionKorea, Republic of
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RenJi HospitalCompletedST Segment Elevation Myocardial Infarction
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Dong-A UniversityTerminatedST-Segment Elevation Myocardial InfarctionKorea, Republic of
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Azienda Ospedaliera San Camillo ForlaniniUnknownST Segment Elevation Myocardial InfarctionItaly
-
Jinan Central HospitalUnknownST-Segment Elevation Myocardial InfarctionChina
Clinical Trials on Oral Ticagrelor
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PhaseBio Pharmaceuticals Inc.Completed
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PhaseBio Pharmaceuticals Inc.CompletedHealthyUnited States
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Collegium Medicum w BydgoszczyCompleted
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Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
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University of FloridaCompleted
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AstraZenecaParexelCompletedSickle Cell DiseaseGermany
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Second Affiliated Hospital, School of Medicine,...UnknownAtrial Fibrillation | Acute Coronary Syndromes
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Kafrelsheikh UniversityCompleted
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University of FloridaAstraZenecaCompleted