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

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ClinicalTrials.gov Identifier: NCT01848899
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
NYU Langone Health

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
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description Ioxaglate: contrast media used during coronary angiography Iodixanol: contrast media used during coronary angiography
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Ioxaglate Arm Iodixanol Arm Total
Hide Arm/Group Description Ioxaglate: contrast media used during coronary angiography Iodixanol: contrast media used during coronary angiography Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  34.0%
22
  44.0%
39
  39.0%
>=65 years
33
  66.0%
28
  56.0%
61
  61.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
13
  26.0%
11
  22.0%
24
  24.0%
Male
37
  74.0%
39
  78.0%
76
  76.0%
1.Primary Outcome
Title Thrombin Generation Test: Baseline
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description:
Ioxaglate: contrast media used during coronary angiography
Iodixanol: contrast media used during coronary angiography
Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: nM*minutes
1810
(1540 to 2089)
1682
(1534 to 2147)
2.Primary Outcome
Title Thrombin Generation Test: After Coronary Angiography
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description:
Ioxaglate: contrast media used during coronary angiography
Iodixanol: contrast media used during coronary angiography
Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: nM*minutes
649
(314 to 1347)
681
(229 to 1237)
3.Secondary Outcome
Title Percent Change in Maximal Platelet Aggregation: Epinephrine
Hide Description Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine
Time Frame Baseline to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description:
Ioxaglate: contrast media used during coronary angiography
Iodixanol: contrast media used during coronary angiography
Overall Number of Participants Analyzed 46 47
Median (Inter-Quartile Range)
Unit of Measure: Percent change
5.4
(-8.2 to 27.0)
25.7
(.9 to 42.3)
4.Secondary Outcome
Title Percent Change in Maximal Platelet Aggregation: Arachidonic Acid
Hide Description Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description:
Ioxaglate: contrast media used during coronary angiography
Iodixanol: contrast media used during coronary angiography
Overall Number of Participants Analyzed 45 47
Median (Inter-Quartile Range)
Unit of Measure: Percent change
38.1
(10.7 to 74.3)
36.0
(4.4 to 109.8)
5.Secondary Outcome
Title Percent Change in Maximal Platelet Aggregation: ADP
Hide Description Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description:
Ioxaglate: contrast media used during coronary angiography
Iodixanol: contrast media used during coronary angiography
Overall Number of Participants Analyzed 47 48
Median (Inter-Quartile Range)
Unit of Measure: Percent change
-3
(-8.4 to 1.7)
.05
(-5.9 to 4.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ioxaglate Arm Iodixanol Arm
Hide Arm/Group Description Ioxaglate: contrast media used during coronary angiography Iodixanol: contrast media used during coronary angiography
All-Cause Mortality
Ioxaglate Arm Iodixanol Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ioxaglate Arm Iodixanol Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ioxaglate Arm Iodixanol Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      1/50 (2.00%)    
Gastrointestinal disorders     
Nausea  1/50 (2.00%)  1 0/50 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hives/rash  1/50 (2.00%)  1 1/50 (2.00%)  1
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
Layout table for Results Point of Contact information
Name/Title: Binita Shah
Organization: NYU Langone Medical Center
Phone: 212-263-4235
EMail: binita.shah@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01848899    
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