Trial Outcomes & Findings for Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography (NCT NCT01475097)
NCT ID: NCT01475097
Last Updated: 2014-06-11
Results Overview
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
255 participants
Primary outcome timeframe
Within 10 minutes post contrast administration.
Results posted on
2014-06-11
Participant Flow
255 subjects were enrolled in this study. Two (2) subjects did not complete the study. Total number of subjects that completed the study was 253.
Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.
Participant milestones
| Measure |
Iodixanol 320mgI/mL
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
127
|
|
Overall Study
COMPLETED
|
127
|
126
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Iodixanol 320mgI/mL
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
Baseline characteristics by cohort
| Measure |
Iodixanol 320mgI/mL
n=127 Participants
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
n=126 Participants
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 13.34 • n=99 Participants
|
62.0 years
STANDARD_DEVIATION 15.30 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 14.38 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
24 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
38 participants
n=99 Participants
|
39 participants
n=107 Participants
|
77 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
57 participants
n=99 Participants
|
58 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 10 minutes post contrast administration.Population: 249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
Outcome measures
| Measure |
Iodixanol 320mgI/mL
n=124 Participants
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
n=125 Participants
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
Discomfort
|
53 participants
|
92 participants
|
|
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
Heat
|
48 participants
|
82 participants
|
|
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
Pain
|
5 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Within 10 minutes post contrast administration.Population: A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis. This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis.
Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Outcome measures
| Measure |
Iodixanol 320mgI/mL
n=126 Participants
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
n=125 Participants
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
Excellent
|
109 participants
|
103 participants
|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
Adequate
|
16 participants
|
19 participants
|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
Poor
|
1 participants
|
3 participants
|
Adverse Events
Iodixanol 320mgI/mL
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Iopamidol 370mgI/mL
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iodixanol 320mgI/mL
n=127 participants at risk
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
n=126 participants at risk
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
2/127 • Number of events 2
|
0.00%
0/126
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/127
|
0.79%
1/126 • Number of events 1
|
|
General disorders
Vessel Puncture Site Hematoma
|
0.79%
1/127 • Number of events 1
|
0.00%
0/126
|
|
Gastrointestinal disorders
Retroperitoneal Hemorrhage
|
0.00%
0/127
|
0.79%
1/126 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/127
|
0.79%
1/126 • Number of events 1
|
|
Vascular disorders
Hemorrhage from femoral common artery
|
0.00%
0/127
|
0.79%
1/126 • Number of events 1
|
|
Vascular disorders
Hypovolemic Shock
|
0.00%
0/127
|
0.79%
1/126 • Number of events 1
|
Other adverse events
| Measure |
Iodixanol 320mgI/mL
n=127 participants at risk
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
Iopamidol 370mgI/mL
n=126 participants at risk
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
|
|---|---|---|
|
Eye disorders
Photopsia
|
5.5%
7/127 • Number of events 7
|
0.79%
1/126 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.3%
8/127 • Number of events 8
|
1.6%
2/126 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place