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

Coronary Artery Disease Clinical Trial

Official title:
The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial

Clinical Trial Summary

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.

Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the United States annually. Despite the use of antiplatelet and anticoagulant pharmacotherapy, thrombotic complications of PCI continue to cause significant morbidity, especially in already high risk patients. In addition to adjunctive anti- thrombotic and anti-platelet therapy, the type of contrast agent used may also affect thrombus formation by directly affecting specific coagulation factors, fibrinolytic factors, and platelet degranulation, aggregation, or adhesion.

Optimizing thrombotic risk in patients requiring coronary angiography with or without intervention is paramount to patient care. This is especially true if a type of contrast agent is found to have a superior role in reducing factors known to increase peri-procedural thromboembolic events.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01848899
Study type Interventional
Source New York University School of Medicine
Contact
Status Completed
Phase Phase 4
Start date February 2013
Completion date November 2014
View Details
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