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A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Primary Purpose

Stable Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Coronary Artery Disease focused on measuring Stable Coronary Artery Disease, CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Outcomes

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
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
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
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
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
The SD is a statistic using the log-transformed data and is not the geometric SD.

Full Information

First Posted
January 30, 2012
Last Updated
August 14, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01523366
Brief Title
A Pharmacodynamic Study With Ticagrelor in Hispanic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic 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 Hispanic Patients with Stable Coronary Artery Disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease
Keywords
Stable Coronary Artery Disease, CAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Title
Clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Min - 90mg/Max - 180mg tablets (loading dose)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75mg (once daily)/Max - 600mg tablets (loading dose)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
At 2 hours after the loading dose
Secondary Outcome Measure Information:
Title
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose
Description
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
Time Frame
At 0.5 and 8 hours after the loading dose
Title
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
Description
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
Time Frame
At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8
Title
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
Description
The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.
Time Frame
Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose
Title
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
Description
The SD is a statistic using the log-transformed data and is not the geometric SD.
Time Frame
Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Carlson, MD
Organizational Affiliation
AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Linden
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=484&filename=D5130L00012_Clinical_Study_Protocol_Redacted_4-9-14_Redacted.pdf
Description
D5130L00012_Clinical_Study_Protocol_Redacted
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=484&filename=D5130L00012_CSR_Synopsis_01Apr2014.pdf
Description
CSR_Synopsis

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A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

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