Chewed Versus Integral Pill of Ticagrelor
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|ClinicalTrials.gov Identifier: NCT03708588|
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Coronary Intervention||Drug: Ticagrelor||Phase 4|
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.
Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
- 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 TIMI criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.|
|Actual Study Start Date :||September 19, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
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 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)
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 PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)
- Concentration of pharmacodynamics [ Time Frame: 1 hour ]Measure platelet reactivity
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708588
|Contact: Thomas F Wilson, MD||(414) email@example.com|
|Contact: Gina Behrfirstname.lastname@example.org|
|United States, Wisconsin|
|Aurora Health Care, St. Luke's Medical Center||Recruiting|
|Milwaukee, Wisconsin, United States, 53215|
|Contact: Wendy Dunaj 414-649-3512 email@example.com|
|Principal Investigator: Thomas Wilson, MD|
|Principal Investigator:||Thomas F Wilson, MD||Aurora Health Care|