The ACS Ethnicity Platelet Function Study

Study Overview
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Brief Summary
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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.

Official Title
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The ACS Ethnicity Platelet Function Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female (post menopausal or surgically sterile) and/or male aged 18 years or older Presenting with ACS fulfilling the following: Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG) Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN) Self-identified as African-American Treatment with 75-100mg ASA daily Exclusion Criteria: Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period. Fibrinolytic therapy within 48 hours before randomization Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer) Increased bleeding risk including: recent (<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin <10 g/dL. Any history of hemorrhagic stroke. Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing). Severe renal failure (creatinine clearance <30mL/min or patient requires dialysis) History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin > 1.5 x upper limit of the reference range. Pregnant or lactating women. Patients receiving any glycoprotein IIb/IIIa inhibitors <8 hours before platelet reactivity testing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AA Ticagrelor<br>African Americans who present with acute coronary syndrome (ACS) to the cath lab, and receive ticagrelor during their hospital stay. | Drug: Ticagrelor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ticagrelor Inhibition | 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. | 1-2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up Adverse Events | To evaluate the safety of ticagrelor treatment in African-American patients by assessment of adverse-events up to 30-day follow-up time point. | 30 days |