Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

This study has been completed.
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01848899
First received: April 23, 2013
Last updated: March 7, 2016
Last verified: March 2016

April 23, 2013
March 7, 2016
February 2013
November 2013   (final data collection date for primary outcome measure)
  • Thrombin Generation Test: Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
change in thrombin generation test from baseline to after coronary angiography
Complete list of historical versions of study NCT01848899 on ClinicalTrials.gov Archive Site
  • Percent Change in Maximal Platelet Aggregation: Epinephrine [ Time Frame: Baseline to 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
  • thrombin-antithrombin (TAT) complex [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • fibrinopeptide A [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • prothrombin fragment 1+2 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • monocyte and leukocyte platelet aggregates [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • light transmission aggregometry [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Coronary Artery Disease
  • Drug: Iodixanol
    contrast media used during coronary angiography
    Other Name: Visipaque
  • Drug: Ioxaglate
    contrast media used during coronary angiography
    Other Name: Hexabrix
  • Drug: Bivalirudin
    A direct thrombin inhibitor
    Other Names:
    • Angiomax
    • Angiox
  • Experimental: Ioxaglate Arm
    Interventions:
    • Drug: Ioxaglate
    • Drug: Bivalirudin
  • Experimental: Iodixanol arm
    Interventions:
    • Drug: Iodixanol
    • Drug: Bivalirudin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2014
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01848899
12-02409
No
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
Guerbet
Principal Investigator: Fred Feit, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
New York University School of Medicine
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP