A Pharmacodynamic Study With Ticagrelor in African American Patients

AstraZeneca50 enrolled

Overview

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stable Coronary Artery Disease

Interventions

TicagrelorDRUG

Min - 90mg/Max - 180mg tablets (loading dose)

ClopidogrelDRUG

75mg (once daily)/Max - 600mg tablets (loading dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 African American 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 required dialysis

Locations (8)

Research Site

Newark, Delaware, United States

Research Site

Wilmington, Delaware, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Hollywood, Florida, United States

Outcomes

Primary Outcomes

Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose

Time frame: At 2 hours after the loading dose

Secondary Outcomes

Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose

Time frame: At 0.5 hour and 8 hours after the loading dose

Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8

Time frame: At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8

Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is the geometric SD

Time frame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose

AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is the geometric SD

Time frame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose

Data from ClinicalTrials.gov

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