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

NCT ID: NCT01118325

Last Updated: 2014-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stable Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD6140 45 mg bd

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

Drug oral treatment

AZD6140 90 mg bd

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

Drug oral treatment

Clopidogrel 75 mg od

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

Drug oral treatment

Interventions

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ticagrelor

Drug oral treatment

Intervention Type DRUG

clopidogrel

Drug oral treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan C. Fox, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Miyaodai, Fukuoka, Japan

Site Status

Research Site

Sapporo, Hokkaido, Japan

Site Status

Research Site

Toride-shi, Ibaraki, Japan

Site Status

Research Site

Kawasaki-shi, Kanagawa, Japan

Site Status

Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Ōita, Oita Prefecture, Japan

Site Status

Research Site

Naha, Okinawa, Japan

Site Status

Research Site

Osaka, Osaka, Japan

Site Status

Research Site

Kusatsu-shi, Shiga, Japan

Site Status

Research Site

Komatsushima-shi, Tokushima, Japan

Site Status

Research Site

Shinagawa-ku, Tokyo, Japan

Site Status

Research Site

Davao City, , Philippines

Site Status

Research Site

Quezon City, , Philippines

Site Status

Countries

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Japan Philippines

References

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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.

Reference Type BACKGROUND
PMID: 24935072 (View on PubMed)

Other Identifiers

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D5130C00065

Identifier Type: -

Identifier Source: org_study_id

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