- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708588
Chewed Versus Integral Pill of Ticagrelor
Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
Secondary Hypotheses:
Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
- Death
- Repeat myocardial infarction
- Need for urgent revascularization
- Cerebrovascular accident
- Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.
- Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Aurora Health Care, St. Luke's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
Exclusion Criteria:
- Age <18 years or Age >89 years
- Known coagulopathy, bleeding diathesis, or active bleeding
- History of recent gastrointestinal or genitourinary bleed within 2 months
- Known chronic therapy with clopidogrel, prasugrel, or ticagrelor
- Major surgery within last 6 weeks
- History of intracranial bleed or intracranial neoplasm
- Suspected aortic dissection
- Severe hemodynamic instability, cardiogenic shock
- Life expectancy <1 year
- Known severe liver or renal disease
- Known HIV treatment
- Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure
- Any use of Cangrelor during or after the procedure
- Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L
- Pregnancy
- Known allergy to study medication
Study Plan
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 |
---|---|
Experimental: Experimental: Chewed ticagrelor
Drug: Ticagrelor chewed pills.
The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI.
Patients will be asked to chew, but not swallow, allowing for sublingual absorption.
(Loading dose 180mg)
|
Chewed
Other Names:
Integral
Other Names:
|
Active Comparator: Active Comparator: Integral pill
Drug: Ticagrelor integral pills.
The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI.
Patients will swallow the loading dose followed by 25-50mL (milliliter) of water.
(180mg)
|
Chewed
Other Names:
Integral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Pharmacodynamics
Time Frame: 1 hour
|
Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA).
This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
Time Frame: 30 days
|
Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.
|
30 days
|
Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
Time Frame: 1 year
|
Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suhail Allaqaband, MD, Aurora Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-078_18-911
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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