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An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease

Primary Purpose

Stable Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
International
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, Platelet Aggregation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
  • Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
  • Treatment with ASA

Exclusion Criteria:

  • ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
  • Known concurrent disease of stroke or TIA with atrial fibrillation
  • Persons who are being treated with blood clotting agents that cannot be stopped

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

AZD6140 45 mg bd

AZD6140 90 mg bd

Clopidogrel 75 mg od

Arm Description

Outcomes

Primary Outcome Measures

Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients
Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.

Secondary Outcome Measures

AZD6140 (Cmax) at Week 4
Maximum plasma AZD6140 concentration
AZD6140 (AUC0-tau) at Week 4
Area under the plasma concentration curve of AZD6140 from time zero to dosing interval
AZD6140 (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration
AR-C124910XX (Cmax) at Week 4
Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX
AR-C124910XX (AUC0-tau) at Week 4
Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval
AR-C124910XX (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration

Full Information

First Posted
April 30, 2010
Last Updated
June 24, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01118325
Brief Title
An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
Official Title
A Randomised, Double-Blind, Parallel Group, Asian, Multicenter Study, to Assess Pharmacokinetic and Pharmacodynamic Profile of 2 Doses of Ticagrelor on Top of Low Dose Acetyl Salicylic Acid (ASA) Therapy on Platelet Aggregation in Japanese and Asian Patients With Stable Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.

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, Platelet Aggregation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD6140 45 mg bd
Arm Type
Experimental
Arm Title
AZD6140 90 mg bd
Arm Type
Experimental
Arm Title
Clopidogrel 75 mg od
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Intervention Description
Drug oral treatment
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
Drug oral treatment
Primary Outcome Measure Information:
Title
Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients
Description
Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
Time Frame
Week 4
Title
IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients
Description
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
Time Frame
Week 4
Title
IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients
Description
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
Time Frame
Week 4
Title
IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients
Description
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
Time Frame
Week 4
Title
IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients
Description
Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
AZD6140 (Cmax) at Week 4
Description
Maximum plasma AZD6140 concentration
Time Frame
Week 4
Title
AZD6140 (AUC0-tau) at Week 4
Description
Area under the plasma concentration curve of AZD6140 from time zero to dosing interval
Time Frame
Week 4
Title
AZD6140 (Tmax) at Week 4
Description
Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration
Time Frame
Week 4
Title
AR-C124910XX (Cmax) at Week 4
Description
Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX
Time Frame
Week 4
Title
AR-C124910XX (AUC0-tau) at Week 4
Description
Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval
Time Frame
Week 4
Title
AR-C124910XX (Tmax) at Week 4
Description
Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any Percutaneous Coronary Intervention, more than 3 months prior to randomization Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation Treatment with ASA Exclusion Criteria: ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation Known concurrent disease of stroke or TIA with atrial fibrillation Persons who are being treated with blood clotting agents that cannot be stopped
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan C. Fox, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Mizumaki
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Toride-shi
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Naha-shi
State/Province
Okinawa
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kusatsu-shi
State/Province
Shiga
Country
Japan
Facility Name
Research Site
City
Komatsushima-shi
State/Province
Tokushima
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
24935072
Citation
Hiasa Y, Teng R, Emanuelsson H. Pharmacodynamics, pharmacokinetics and safety of ticagrelor in Asian patients with stable coronary artery disease. Cardiovasc Interv Ther. 2014 Oct;29(4):324-33. doi: 10.1007/s12928-014-0277-1. Epub 2014 Jun 17.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=374&filename=CSR-D5130C00065.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=374&filename=CSR-D5130C00065.pdf
Description
CSR-D5130C00065.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=374&filename=D5130C00065_CSP_Redacted_17_Oct_2013.pdf
Description
D5130C00065_CSP_redacted_17_Oct_2013

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An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease

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