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
  Purpose

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.


Condition Intervention Phase
Stable Coronary Artery Disease
Drug: Ticagrelor
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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 Hispanic Patients With Stable Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 53
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor Drug: Ticagrelor
Min - 90mg/Max - 180mg tablets (loading dose)
Active Comparator: Clopidogrel Drug: Clopidogrel
75mg (once daily)/Max - 600mg tablets (loading dose)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523366

Locations
United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
United States, New Jersey
Research Site
Linden, New Jersey, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Glenn Carlson, MD AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01523366     History of Changes
Other Study ID Numbers: D5130L00012
Study First Received: January 30, 2012
Results First Received: May 10, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Stable Coronary Artery Disease, CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014