Maintenance of Platelet Inhibition With Cangrelor

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.

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Detailed Description

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Conditions

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Acute Coronary Syndrome (ACS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cangrelor

Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

Placebo

A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Interventions

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cangrelor

Intervention Type DRUG

Placebo

Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* 18 Years of Age
* Non emergent coronary bypass graft surgery
* Received a thienopyridine within 48 hours prior to enrollment

Exclusion Criteria

* Confirmed or suspected pregnancy
* Cerebrovascular accident within one yar
* Intracranial neoplasm
* History of bleeding diathesis
* Thrombocytopenia

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No