The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
| Registry | NCT01848899 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: single |
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| Enrollment | 100 (Actual) |
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| Sponsor | NYU Langone Health (Other); collaborators: Guerbet |
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| Conditions | Coronary Artery Disease |
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| Interventions | Iodixanol, Ioxaglate, Bivalirudin (Drug) |
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| Dates | start 2013-02-01, primary completion 2013-11-01, completion 2014-11-01, first posted 2013-05-08, last updated 2016-04-06 |
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| Locations | 1 site in United States |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Ioxaglate Arm | Experimental | Drug: Ioxaglate; Drug: Bivalirudin | |
| Iodixanol arm | Experimental | Drug: Iodixanol; Drug: Bivalirudin | |
- Iodixanol (Drug), also known as Visipaque: contrast media used during coronary angiography
- Ioxaglate (Drug), also known as Hexabrix: contrast media used during coronary angiography
- Bivalirudin (Drug), also known as Angiomax, Angiox: A direct thrombin inhibitor
+Outcome measures
Primary outcomes
- Thrombin Generation Test: Baseline [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.
- Thrombin Generation Test: After Coronary Angiography [1 hour]: 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.
Secondary outcomes
- Percent Change in Maximal Platelet Aggregation: Epinephrine [Baseline to 1 hour]: Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine
- Percent Change in Maximal Platelet Aggregation: Arachidonic Acid [1 hour]: Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid
- Percent Change in Maximal Platelet Aggregation: ADP [1 hour]: Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
+Eligibility
Sex: All, ages: 18 Years to any
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.
+Posted results
Participant flow
| Milestone | Ioxaglate Arm | Iodixanol Arm |
|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
Outcome results
- Thrombin Generation Test: Baseline (Primary), Median, nM*minutes: Ioxaglate Arm 1810 (1540 to 2089); Iodixanol Arm 1682 (1534 to 2147)
- Percent Change in Maximal Platelet Aggregation: Epinephrine (Secondary), Median, Percent change: Ioxaglate Arm 5.4 (-8.2 to 27.0); Iodixanol Arm 25.7 (.9 to 42.3)
- Percent Change in Maximal Platelet Aggregation: Arachidonic Acid (Secondary), Median, Percent change: Ioxaglate Arm 38.1 (10.7 to 74.3); Iodixanol Arm 36.0 (4.4 to 109.8)
- Percent Change in Maximal Platelet Aggregation: ADP (Secondary), Median, Percent change: Ioxaglate Arm -3 (-8.4 to 1.7); Iodixanol Arm .05 (-5.9 to 4.4)
- Thrombin Generation Test: After Coronary Angiography (Primary), Median, nM*minutes: Ioxaglate Arm 649 (314 to 1347); Iodixanol Arm 681 (229 to 1237)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Ioxaglate Arm | 0 | 0/50 (0.0%) | 2/50 (4.0%) |
| Iodixanol Arm | 0 | 0/50 (0.0%) | 1/50 (2.0%) |
Other adverse events by term
| Term | Organ system | Ioxaglate Arm | Iodixanol Arm |
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| Hives/rash | Skin and subcutaneous tissue disorders | 1/50 | 1/50 |
| Nausea | Gastrointestinal disorders | 1/50 | 0/50 |
+Locations (1)
| Facility | City | Country | Status |
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| New York University School of Medicine | New York, New York | United States | |
+Investigators