Coronary Artery Disease
Conditions
Keywords
Coronary angiography, Percutaneous coronary intervention, Contrast media, Platelet activity, Thrombin generation, Fibrinolysis
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.
Interventions
DRUGIodixanol
contrast media used during coronary angiography
DRUGIoxaglate
contrast media used during coronary angiography
DRUGBivalirudin
A direct thrombin inhibitor
Sponsors
Guerbet
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ioxaglate Arm Ioxaglate: contrast media used during coronary angiography | 50 |
| Iodixanol Arm Iodixanol: contrast media used during coronary angiography | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Ioxaglate Arm | Iodixanol Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 28 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 37 Participants | 39 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: 1 hour
Population: A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ioxaglate Arm | Thrombin Generation Test: After Coronary Angiography | 649 nM*minutes |
| Iodixanol Arm | Thrombin Generation Test: After Coronary Angiography | 681 nM*minutes |
Primary
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.
Time frame: baseline
Population: A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ioxaglate Arm | Thrombin Generation Test: Baseline | 1810 nM*minutes |
| Iodixanol Arm | Thrombin Generation Test: Baseline | 1682 nM*minutes |
Secondary
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
Time frame: 1 hour
Population: Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ioxaglate Arm | Percent Change in Maximal Platelet Aggregation: ADP | -3 Percent change |
| Iodixanol Arm | Percent Change in Maximal Platelet Aggregation: ADP | .05 Percent change |
Secondary
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
Time frame: 1 hour
Population: Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ioxaglate Arm | Percent Change in Maximal Platelet Aggregation: Arachidonic Acid | 38.1 Percent change |
| Iodixanol Arm | Percent Change in Maximal Platelet Aggregation: Arachidonic Acid | 36.0 Percent change |
Secondary
Percent Change in Maximal Platelet Aggregation: Epinephrine
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine
Time frame: Baseline to 1 hour
Population: Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ioxaglate Arm | Percent Change in Maximal Platelet Aggregation: Epinephrine | 5.4 Percent change |
| Iodixanol Arm | Percent Change in Maximal Platelet Aggregation: Epinephrine | 25.7 Percent change |