Clinical trial NCT01523392: A Pharmacodynamic Study With Ticagrelor in African American Patients
Official title: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease, CAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At 2 hours after the loading dose
Secondary outcomes:
measure: Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose
timeFrame: At 0.5 hour and 8 hours after the loading dose
measure: 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
timeFrame: At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8
measure: Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
timeFrame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose
measure: AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
timeFrame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose
Other outcomes:
Locations:
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Beaumont
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA
name: Glenn Carlson, MD
role: STUDY_DIRECTOR
References:
citation: 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.