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

Study Overview
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Iodixanol
* Drug: Ioxaglate
* Drug: Bivalirudin


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ioxaglate Arm<br> | Drug: Ioxaglate<br>* contrast media used during coronary angiography<br>* Other names: Hexabrix;Drug: Bivalirudin<br>* A direct thrombin inhibitor<br>* Other names: Angiox;|
| Experimental: Iodixanol arm<br> | Drug: Iodixanol<br>* contrast media used during coronary angiography<br>* Other names: Visipaque;Drug: Bivalirudin<br>* A direct thrombin inhibitor<br>* Other names: Angiox;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, Percutaneous coronary intervention, Contrast media, Platelet activity, Thrombin generation, Fibrinolysis