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A Pharmacodynamic Study With Ticagrelor in African American Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01523392
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : September 26, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Drug: Ticagrelor Drug: Clopidogrel Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ticagrelor Drug: Ticagrelor
Min - 90mg/Max - 180mg tablets (loading dose)
Active Comparator: Clopidogrel Drug: Clopidogrel
75mg (once daily)/Max - 600mg tablets (loading dose)


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: At 2 hours after the loading dose ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses [ Time Frame: 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

  4. AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses [ 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 ]
    The standard deviation (SD) is the geometric SD


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523392


Locations
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United States, Delaware
Research Site
Newark, Delaware, United States
Research Site
Wilmington, Delaware, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Maryland
Research Site
Towson, Maryland, United States
United States, Texas
Research Site
Beaumont, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Glenn Carlson, MD AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01523392    
Other Study ID Numbers: D5130L00013
First Posted: February 1, 2012    Key Record Dates
Results First Posted: September 26, 2014
Last Update Posted: October 8, 2014
Last Verified: September 2014
Keywords provided by AstraZeneca:
Stable Coronary Artery Disease, CAD
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs