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A Comparison of Ticagrelor (A...

A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

Last Updated: 2012-03-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-03-31

Brief Summary

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Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clopidogrel

Oral treatment

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 75 mg once daily dose (ODD)

Ticagrelor

Oral treatment

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Interventions

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Ticagrelor

Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Intervention Type DRUG

Clopidogrel

Clopidogrel 75 mg once daily dose (ODD)

Intervention Type DRUG

Other Intervention Names

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AZD6140 Plavix®

Eligibility Criteria

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Inclusion Criteria

* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria

* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers