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Completed

NCT Number: NCT01848899

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iodixanol

Drug

contrast media used during coronary angiography

Other names: Visipaque

Ioxaglate

Drug

contrast media used during coronary angiography

Other names: Hexabrix

Bivalirudin

Drug

A direct thrombin inhibitor

Other names: Angiomax, Angiox

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Guerbet

Registry information

Official study title

The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 8, 2013
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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