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

• 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: NYU Langone Health
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ioxaglate Arm	Iodixanol Arm
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

Baseline Characteristics

Arm/Group Title		Ioxaglate Arm	Iodixanol Arm	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Thrombin Generation Test: Baseline
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine
Time Frame	Baseline to 1 hour

Outcome Measure Data

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
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
Description	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid
Time Frame	1 hour

Outcome Measure Data

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
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
Description	Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
Time Frame	1 hour

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Ioxaglate Arm		Iodixanol Arm
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	--/--		--/--
Serious Adverse Events
	Ioxaglate Arm		Iodixanol Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0.00%)		0/50 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: binita.shah@nyumc.org

• 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