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):
Frederick Feit, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01848899
First received: April 23, 2013
Last updated: October 8, 2014
Last verified: October 2014

April 23, 2013
October 8, 2014
February 2013
November 2013   (final data collection date for primary outcome measure)
thrombin generation test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
change in thrombin generation test from baseline to after coronary angiography
Same as current
Complete list of historical versions of study NCT01848899 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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.

Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the United States annually. Despite the use of antiplatelet and anticoagulant pharmacotherapy, thrombotic complications of PCI continue to cause significant morbidity, especially in already high risk patients. In addition to adjunctive anti- thrombotic and anti-platelet therapy, the type of contrast agent used may also affect thrombus formation by directly affecting specific coagulation factors, fibrinolytic factors, and platelet degranulation, aggregation, or adhesion.

Optimizing thrombotic risk in patients requiring coronary angiography with or without intervention is paramount to patient care. This is especially true if a type of contrast agent is found to have a superior role in reducing factors known to increase peri-procedural thromboembolic events.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Patients Referred for Coronary Angiography
Drug: Type of contrast administered during coronary angiography (ioxaglate or iodixanol)
  • Experimental: Randomized arm
    The study will be a prospective, randomized study of patients (n=100) undergoing coronary angiography. Patients will be randomly assigned to either receive ioxaglate or iodixanol during coronary angiography. The primary outcome measure will be a change in thrombin generation test from baseline to after coronary angiography. Secondary outcomes will include a change in other markers of platelet activity and thrombogenesis between baseline and after coronary angiography. In addition, in patients undergoing PCI, differences in markers after the administration of bivalirudin and after PCI will be evaluated.
    Intervention: Drug: Type of contrast administered during coronary angiography (ioxaglate or iodixanol)
  • No Intervention: Registry cohort
    In addition, we will have a registry for patients (n=30) requiring emergent cardiac catheterization for ST-segment elevation myocardial infarction (no randomization component; choice of contrast will be left up to operator preference). Blood samples will be obtained from arterial sheath at the beginning and at the end of the procedure (2 time points).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
May 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01848899
S12-02409
No
Frederick Feit, 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
October 2014

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