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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ioxaglate; Drug: Bivalirudin; Drug: Iodixanol

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ioxaglate Arm	Drug: Ioxaglate; contrast media used during coronary angiography; Other Names: Hexabrix; Drug: Bivalirudin; A direct thrombin inhibitor; Other Names: Angiomax; Angiox
Experimental: Iodixanol arm	Drug: Bivalirudin; A direct thrombin inhibitor; Other Names: Angiomax; Angiox; Drug: Iodixanol; contrast media used during coronary angiography; Other Names: Visipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombin Generation Test: Baseline	The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.	baseline
Thrombin Generation Test: After Coronary Angiography	The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Maximal Platelet Aggregation: Epinephrine	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine	Baseline to 1 hour
Percent Change in Maximal Platelet Aggregation: Arachidonic Acid	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid	1 hour
Percent Change in Maximal Platelet Aggregation: ADP	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP	1 hour

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Guerbet
• Investigators: Principal Investigator: Fred Feit, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Coronary angiography; Percutaneous coronary intervention; Fibrinolysis; Contrast media; Platelet activity; Thrombin generation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Bivalirudin
• Other Study ID Numbers: 12-02409