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 Details — Status: Completed

Administrative data

• NCT number: NCT01848899
• Other study ID #: S12-02409
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2013
• Last updated: November 11, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry

• 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.

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• contrast media (ioxaglate or iodixanol)
contrast media used during coronary angiography

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombin generation test	change in thrombin generation test from baseline to after coronary angiography	1 hour	No
Secondary	thrombin-antithrombin (TAT) complex		1 hour	No
Secondary	fibrinopeptide A		1 hour	No
Secondary	prothrombin fragment 1+2		1 hour	No
Secondary	monocyte and leukocyte platelet aggregates		1 hour	No
Secondary	light transmission aggregometry		1 hour	No