Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

NCT ID: NCT01848899

Last Updated: 2016-04-06

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-11-30

Brief Summary

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The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ioxaglate Arm

Group Type EXPERIMENTAL

Ioxaglate

Intervention Type DRUG

contrast media used during coronary angiography

Bivalirudin

Intervention Type DRUG

A direct thrombin inhibitor

Iodixanol arm

Group Type EXPERIMENTAL

Iodixanol

Intervention Type DRUG

contrast media used during coronary angiography

Bivalirudin

Intervention Type DRUG

A direct thrombin inhibitor

Interventions

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Iodixanol

contrast media used during coronary angiography

Intervention Type DRUG

Ioxaglate

contrast media used during coronary angiography

Intervention Type DRUG

Bivalirudin

A direct thrombin inhibitor

Intervention Type DRUG

Other Intervention Names

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Visipaque Hexabrix Angiomax Angiox

Eligibility Criteria

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Inclusion Criteria

* Patients must be more than 18 years of age
* referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).

Exclusion Criteria

* on warfarin
* on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time \>150 at time of procedure -on cilostazol
* on persantine
* on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
* undergoing coronary angiography via radial access
* undergoing planned diagnostic coronary angiography only
* unable to tolerate dual anti-platelet therapy
* with known allergy to CM
* received CM within 24 hours of coronary angiography
* on dialysis
* do not consent or are unable to give consent
* are participating in another competing study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Feit, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Binita Shah, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12-02409

Identifier Type: -

Identifier Source: org_study_id

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