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

NYU Langone Health logo

NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Ioxaglate
Drug: Iodixanol
Drug: Bivalirudin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01848899
12-02409

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Ioxaglate Arm
Experimental group
Treatment:
Drug: Bivalirudin
Drug: Ioxaglate
Iodixanol arm
Experimental group
Treatment:
Drug: Bivalirudin
Drug: Iodixanol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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