The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Thrombin Generation Test: Baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ioxaglate Arm
Intervention: Ioxaglate (Drug)
Ioxaglate Arm
Intervention: Bivalirudin (Drug)
Iodixanol arm
Intervention: Iodixanol (Drug)
Iodixanol arm
Intervention: Bivalirudin (Drug)
Outcomes
Primary Outcomes
Thrombin Generation Test: Baseline
Time Frame: 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
Time Frame: 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: ADP(1 hour)
- Percent Change in Maximal Platelet Aggregation: Arachidonic Acid(1 hour)