A Pharmacodynamic Study With Ticagrelor in African American Patients
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
1 other identifier
interventional
50
1 country
8
Brief Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
September 26, 2014
CompletedOctober 8, 2014
September 1, 2014
1.5 years
January 30, 2012
September 22, 2014
September 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
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
Study Arms (2)
Ticagrelor
EXPERIMENTALClopidogrel
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (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
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Towson, Maryland, United States
Research Site
Beaumont, Texas, United States
Related Publications (1)
Waksman R, Maya J, Angiolillo DJ, Carlson GF, Teng R, Caplan RJ, Ferdinand KC. Ticagrelor Versus Clopidogrel in Black Patients With Stable Coronary Artery Disease: Prospective, Randomized, Open-Label, Multiple-Dose, Crossover Pilot Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002232. doi: 10.1161/CIRCINTERVENTIONS.114.002232.
PMID: 26152562DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tomas LG Andersson, MD, PhD
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Glenn Carlson, MD
AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 1, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 8, 2014
Results First Posted
September 26, 2014
Record last verified: 2014-09