DRUG
Iodixanol
contrast media used during coronary angiography
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
Status
Completed
Phase
Phase 4
Enrollment
100
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Ioxaglate
contrast media used during coronary angiography
DRUG
Bivalirudin
A direct thrombin inhibitor
Timeline
From registration to results.
First posted
May 8, 2013
Study start
Feb 2013
Primary completion
Nov 2013
Study completion
Nov 2014
Results posted
Apr 6, 2016
Registry updated
Apr 6, 2016
Outcomes
What the study measures.
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
Time frame · 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
Time frame · 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
Time frame · 1 hour
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
New York University School of Medicine
New York, New York, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Bivalirudin.
NCT IDStudyPhase / statusEnrollmentUpdated
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Peking University First Hospital · Coronary Microvascular Dysfunction
Phase 4
Recruiting
70
2025-08
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.