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
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Coronary Artery Disease
Interventions: Drug: Iodixanol
Drug: Ioxaglate
Drug: Bivalirudin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ioxaglate Arm Ioxaglate: contrast media used during coronary angiography
Iodixanol Arm Iodixanol: contrast media used during coronary angiography

Participant Flow:   Overall Study
    Ioxaglate Arm     Iodixanol Arm  
STARTED     50     50  
COMPLETED     50     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ioxaglate Arm Ioxaglate: contrast media used during coronary angiography
Iodixanol Arm Iodixanol: contrast media used during coronary angiography
Total Total of all reporting groups

Baseline Measures
    Ioxaglate Arm     Iodixanol Arm     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     22     39  
>=65 years     33     28     61  
Gender  
[units: participants]
     
Female     13     11     24  
Male     37     39     76  



  Outcome Measures
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1.  Primary:   Thrombin Generation Test: Baseline   [ Time Frame: baseline ]

2.  Primary:   Thrombin Generation Test: After Coronary Angiography   [ Time Frame: 1 hour ]

3.  Secondary:   Percent Change in Maximal Platelet Aggregation: Epinephrine   [ Time Frame: Baseline to 1 hour ]

4.  Secondary:   Percent Change in Maximal Platelet Aggregation: Arachidonic Acid   [ Time Frame: 1 hour ]

5.  Secondary:   Percent Change in Maximal Platelet Aggregation: ADP   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Binita Shah
Organization: NYU Langone Medical Center
phone: 212-263-4235
e-mail: binita.shah@nyumc.org



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