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A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523366
First received: January 30, 2012
Last updated: August 14, 2014
Last verified: August 2014

January 30, 2012
August 14, 2014
April 2012
May 2013   (final data collection date for primary outcome measure)
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 [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ]
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
Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01523366 on ClinicalTrials.gov Archive Site
  • Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose [ Time Frame: At 0.5 and 8 hours after the loading dose ] [ Designated as safety issue: No ]
    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
  • 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 [ Time Frame: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8 ] [ Designated as safety issue: No ]
    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
  • Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses [ Time Frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose ] [ Designated as safety issue: No ]
    The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.
  • AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses [ Time Frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose ] [ Designated as safety issue: No ]
    The SD is a statistic using the log-transformed data and is not the geometric SD.
  • Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 0.5 and 8 hours after the loading dose ] [ Designated as safety issue: No ]
  • Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2, 8 and 24 hours from last dose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of ticagrelor [ Time Frame: Predose, 0.5, 2, 8 from loading dose; 0, 2, 8 and 24 from last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pharmacodynamic Study With Ticagrelor in Hispanic Patients
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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Stable Coronary Artery Disease
  • Drug: Ticagrelor
    Min - 90mg/Max - 180mg tablets (loading dose)
  • Drug: Clopidogrel
    75mg (once daily)/Max - 600mg tablets (loading dose)
  • Experimental: Ticagrelor
    Intervention: Drug: Ticagrelor
  • Active Comparator: Clopidogrel
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01523366
D5130L00012
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Glenn Carlson, MD AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA
AstraZeneca
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP