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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01848899
• Collaborator: Guerbet (Industry)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Iodixanol; Drug: Ioxaglate; Drug: Bivalirudin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ioxaglate Arm	Drug: Ioxaglate; contrast media used during coronary angiography; Other Names: Hexabrix ; Drug: Bivalirudin; A direct thrombin inhibitor; Other Names: Angiomax Angiox
Experimental: Iodixanol arm	Drug: Iodixanol; contrast media used during coronary angiography; Other Names: Visipaque ; Drug: Bivalirudin; A direct thrombin inhibitor; Other Names: Angiomax Angiox

Outcome Measures

Primary Outcome Measures

1. Thrombin Generation Test: Baseline [baseline]

   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.

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

   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

1. Percent Change in Maximal Platelet Aggregation: Epinephrine [Baseline to 1 hour]

   Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine

2. Percent Change in Maximal Platelet Aggregation: Arachidonic Acid [1 hour]

   Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid

3. Percent Change in Maximal Platelet Aggregation: ADP [1 hour]

   Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Guerbet

Investigators

• Principal Investigator: Fred Feit, MD, NYU Langone Health
• Principal Investigator: Binita Shah, MD, MS, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01848899
• Other Study ID Numbers: 12-02409
• First Posted: May 8, 2013
• Last Update Posted: Apr 6, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by NYU Langone Health: Coronary angiography; Percutaneous coronary intervention; Contrast media; Platelet activity; Thrombin generation; Fibrinolysis
• Additional relevant MeSH terms: Coronary Artery Disease; Bivalirudin

Study Results

Participant Flow

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 Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 34%	22 44%	39 39%
>=65 years	33 66%	28 56%	61 61%
Sex: Female, Male (Count of Participants)
Female	13 26%	11 22%	24 24%
Male	37 74%	39 78%	76 76%

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
Measure Participants	43	37
Median (Inter-Quartile Range) [nM*minutes]	1810	1682

2. 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
Measure Participants	46	47
Median (Inter-Quartile Range) [Percent change]	5.4	25.7

3. 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
Measure Participants	45	47
Median (Inter-Quartile Range) [Percent change]	38.1	36.0

4. 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
Measure Participants	47	48
Median (Inter-Quartile Range) [Percent change]	-3	.05

5. 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
Measure Participants	43	37
Median (Inter-Quartile Range) [nM*minutes]	649	681

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ioxaglate Arm		Iodixanol Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Ioxaglate Arm		Iodixanol Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/50 (4%)		1/50 (2%)
Gastrointestinal disorders
Nausea	1/50 (2%)	1	0/50 (0%)	0
Skin and subcutaneous tissue disorders
Hives/rash	1/50 (2%)	1	1/50 (2%)	1

Limitations/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.