A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Phase 4

Completed

Brief Summary: The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Detailed Description: A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Recruitment & Eligibility

Inclusion Criteria

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
Females must be post menopausal or surgically sterile Self-identified as Hispanic

Exclusion Criteria

Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
Current smokers, including the use of tobacco containing products in the past 1 month of randomization
Patients requiring dialysis

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel	-
Ticagrelor	Ticagrelor	-

Primary Outcome Measures

Name	Time	Method
Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose	At 2 hours after the loading dose	Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

Secondary Outcome Measures

Name	Time	Method
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses	Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose	The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses	Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose	The SD is a statistic using the log-transformed data and is not the geometric SD.
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8	At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8	The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose	At 0.5 and 8 hours after the loading dose	Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value