Trial Outcomes & Findings for Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography (NCT NCT01848899)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

baseline

Results posted on

2016-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ioxaglate Arm Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm Iodixanol: contrast media used during coronary angiography
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ioxaglate Arm n=50 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=50 Participants Iodixanol: contrast media used during coronary angiography	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Ioxaglate Arm n=43 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=37 Participants Iodixanol: contrast media used during coronary angiography
Thrombin Generation Test: Baseline	1810 nM*minutes Interval 1540.0 to 2089.0	1682 nM*minutes Interval 1534.0 to 2147.0

PRIMARY outcome

Timeframe: 1 hour

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Ioxaglate Arm n=43 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=37 Participants Iodixanol: contrast media used during coronary angiography
Thrombin Generation Test: After Coronary Angiography	649 nM*minutes Interval 314.0 to 1347.0	681 nM*minutes Interval 229.0 to 1237.0

SECONDARY outcome

Timeframe: Baseline to 1 hour

Population: 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.

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

Outcome measures

Outcome measures
Measure	Ioxaglate Arm n=46 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=47 Participants Iodixanol: contrast media used during coronary angiography
Percent Change in Maximal Platelet Aggregation: Epinephrine	5.4 Percent change Interval -8.2 to 27.0	25.7 Percent change Interval 0.9 to 42.3

SECONDARY outcome

Timeframe: 1 hour

Population: 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.

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

Outcome measures

Outcome measures
Measure	Ioxaglate Arm n=45 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=47 Participants Iodixanol: contrast media used during coronary angiography
Percent Change in Maximal Platelet Aggregation: Arachidonic Acid	38.1 Percent change Interval 10.7 to 74.3	36.0 Percent change Interval 4.4 to 109.8

SECONDARY outcome

Timeframe: 1 hour

Population: 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.

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

Outcome measures

Outcome measures
Measure	Ioxaglate Arm n=47 Participants Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=48 Participants Iodixanol: contrast media used during coronary angiography
Percent Change in Maximal Platelet Aggregation: ADP	-3 Percent change Interval -8.4 to 1.7	.05 Percent change Interval -5.9 to 4.4

Adverse Events

Ioxaglate Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Iodixanol Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ioxaglate Arm n=50 participants at risk Ioxaglate: contrast media used during coronary angiography	Iodixanol Arm n=50 participants at risk Iodixanol: contrast media used during coronary angiography
Skin and subcutaneous tissue disorders Hives/rash	2.0% 1/50 • Number of events 1	2.0% 1/50 • Number of events 1
Gastrointestinal disorders Nausea	2.0% 1/50 • Number of events 1	0.00% 0/50

Additional Information

Binita Shah

NYU Langone Medical Center

Phone: 212-263-4235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place