A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

AstraZeneca53 enrolled

Overview

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic 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 Hispanic 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 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

Locations (5)

Research Site

Los Angeles, California, United States

Research Site

Hollywood, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Outcomes

Primary Outcomes

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

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

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 and 8 Hours After 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

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

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

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

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

Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.

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

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

The SD is a statistic using the log-transformed data and is not the geometric SD.

Data from ClinicalTrials.gov

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