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

• 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: NYU Langone Health
• Collaborator: Guerbet
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: April 23, 2013
• First Posted Date: May 8, 2013
• Results First Submitted Date: January 29, 2016
• Results First Posted Date: April 6, 2016
• Last Update Posted Date: April 6, 2016
• Study Start Date: February 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 3, 2013)

thrombin generation test [ Time Frame: 1 hour ]

change in thrombin generation test from baseline to after coronary angiography

Current Secondary Outcome Measures (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 (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: Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor)
• Condition: Coronary Artery Disease

Intervention

• 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

• Experimental: Ioxaglate Arm
  Interventions:

  • Drug: Ioxaglate
  • Drug: Bivalirudin
• Experimental: Iodixanol arm
  Interventions:

  • Drug: Iodixanol
  • Drug: Bivalirudin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 7, 2016): 100
• Original Estimated Enrollment (submitted: May 3, 2013): 130
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01848899
• Other Study ID Numbers: 12-02409
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: Guerbet

Investigators

• 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