A Pharmacodynamic Study With Ticagrelor in African American Patients

Phase 4

Completed

• Conditions: Stable Coronary Artery Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT01523392
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American 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 African American Patients with Stable Coronary Artery Disease

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Study Start: 2012-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-09
• Results First Submitted: 2014-09-22
• Results First Submitted QC: 2014-09-22
• Results First Posted: 2014-09-26
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
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	At 2 hours after the loading dose

Secondary Outcome Measures

Name	Time	Method
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose	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	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	Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose	The standard deviation (SD) is the geometric SD
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses	Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose	The standard deviation (SD) is the geometric SD

Trial Locations

Locations (1)

Research Site; 🇺🇸 Beaumont, Texas, United States