Phase 4
N=100
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01848899 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Thrombin Generation Test: Baseline — 1810; 1682 nM*minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Iodixanol (Drug); Ioxaglate (Drug); Bivalirudin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombin Generation Test: Baseline |
1810; 1682 | — |
| PRIMARY Thrombin Generation Test: After Coronary Angiography |
649; 681 | — |
| SECONDARY Percent Change in Maximal Platelet Aggregation: Epinephrine |
5.4; 25.7 | — |
| SECONDARY Percent Change in Maximal Platelet Aggregation: Arachidonic Acid |
38.1; 36.0 | — |
| SECONDARY Percent Change in Maximal Platelet Aggregation: ADP |
-3; .05 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01848899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.