The ACS Ethnicity Platelet Function Study
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|ClinicalTrials.gov Identifier: NCT01829659|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : June 8, 2018
This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed.
Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing.
|Condition or disease||Intervention/treatment|
|Acute Coronary Syndrome||Drug: Ticagrelor|
|Study Type :||Observational|
|Actual Enrollment :||4 participants|
|Official Title:||The ACS Ethnicity Platelet Function Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||May 2016|
African Americans who present with acute coronary syndrome (ACS) to the cath lab, and receive ticagrelor during their hospital stay.
- Ticagrelor Inhibition [ Time Frame: 1-2 days ]The primary objective of the study is to assess ticagrelor's inhibition of platelet activity using 3 assays simultaneously: VerifyNow P2Y12 (PRU), vasodilator-stimulated phosphoprotein phosphorylation (VASP) and light transmission aggregometry (LTA) in African-American patients presenting with ACS.
- Follow-up Adverse Events [ Time Frame: 30 days ]To evaluate the safety of ticagrelor treatment in African-American patients by assessment of adverse-events up to 30-day follow-up time point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829659
|United States, District of Columbia|
|Medstar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Medstar Washington Hospital Center|