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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01848899
First Posted: May 8, 2013
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guerbet
Information provided by (Responsible Party):
New York University School of Medicine
Results First Submitted: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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
First Submitted: April 23, 2013
First Posted: May 8, 2013
Results First Submitted: January 29, 2016
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016