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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848899
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE January 29, 2016
Results First Posted Date  ICMJE April 6, 2016
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
thrombin generation test [ Time Frame: 1 hour ]
change in thrombin generation test from baseline to after coronary angiography
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • thrombin-antithrombin (TAT) complex [ Time Frame: 1 hour ]
  • fibrinopeptide A [ Time Frame: 1 hour ]
  • prothrombin fragment 1+2 [ Time Frame: 1 hour ]
  • monocyte and leukocyte platelet aggregates [ Time Frame: 1 hour ]
  • light transmission aggregometry [ Time Frame: 1 hour ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
Official Title  ICMJE The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ioxaglate Arm
    Interventions:
    • Drug: Ioxaglate
    • Drug: Bivalirudin
  • Experimental: Iodixanol arm
    Interventions:
    • Drug: Iodixanol
    • Drug: Bivalirudin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
130
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848899
Other Study ID Numbers  ICMJE 12-02409
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Guerbet
Investigators  ICMJE
Principal Investigator: Fred Feit, MD NYU Langone Health
Principal Investigator: Binita Shah, MD, MS NYU Langone Health
PRS Account NYU Langone Health
Verification Date March 2016

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