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):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01848899
First received: April 23, 2013
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease
Drug: Iodixanol
Drug: Ioxaglate
Drug: Bivalirudin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Thrombin Generation Test: Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percent Change in Maximal Platelet Aggregation: Epinephrine [ Time Frame: Baseline to 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP


Enrollment: 100
Study Start Date: February 2013
Study Completion Date: November 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ioxaglate Arm Drug: Ioxaglate
contrast media used during coronary angiography
Other Name: Hexabrix
Drug: Bivalirudin
A direct thrombin inhibitor
Other Names:
  • Angiomax
  • Angiox
Experimental: Iodixanol arm Drug: Iodixanol
contrast media used during coronary angiography
Other Name: Visipaque
Drug: Bivalirudin
A direct thrombin inhibitor
Other Names:
  • Angiomax
  • Angiox

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01848899

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Guerbet
Investigators
Principal Investigator: Fred Feit, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01848899     History of Changes
Other Study ID Numbers: 12-02409 
Study First Received: April 23, 2013
Results First Received: January 29, 2016
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Coronary angiography
Percutaneous coronary intervention
Contrast media
Platelet activity
Thrombin generation
Fibrinolysis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on July 27, 2016