Trial Outcomes & Findings for Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study (NCT NCT02576067)
NCT ID: NCT02576067
Last Updated: 2020-04-20
Results Overview
Change in arterial inflammation - The relative change at 8 months as compared to baseline in arterial inflammation as measured by the most diseased segment (MDS) of the index vessel. The MDS is defined as the 1.5 cm segment within the carotid artery (right or left carotid) that demonstrates the highest PET/CT activity, and is calculated as a mean of maximum TBR values derived from 3 contiguous axial segments. The index vessel in turn is defined as the vessel (either aorta, right, or left carotid) with the greatest mean TBR at baseline. (MDS TBR Index Vessel)
COMPLETED
PHASE3
123 participants
baseline and 8 months
2020-04-20
Participant Flow
Participants enrolled period from Dec 2015 to April 2018
Participant milestones
| Measure |
Low Dose Methotrexate
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
63
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
34
|
36
|
Reasons for withdrawal
| Measure |
Low Dose Methotrexate
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
matching placebo
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
2
|
|
Overall Study
study closure of main CIRT trial)
|
0
|
8
|
|
Overall Study
not randomized, failed run-in
|
7
|
0
|
|
Overall Study
screen failure/ re-enrolled
|
0
|
25
|
|
Overall Study
Physician Decision
|
4
|
0
|
Baseline Characteristics
Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study
Baseline characteristics by cohort
| Measure |
Low Dose Methotrexate
n=26 Participants
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
n=27 Participants
matching placebo
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
65 years
n=107 Participants
|
64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
hs-CRP
|
1.4 mg/L
n=99 Participants
|
1.1 mg/L
n=107 Participants
|
1.3 mg/L
n=206 Participants
|
|
Total Cholesterol
|
138.1 mg/dL
n=99 Participants
|
131 mg/dL
n=107 Participants
|
134 mg/dL
n=206 Participants
|
|
LDL cholesterol
|
63 mg/dL
n=99 Participants
|
66 mg/dL
n=107 Participants
|
64 mg/dL
n=206 Participants
|
|
HDL cholesterol
|
42.5 mg/dL
n=99 Participants
|
40 mg/dL
n=107 Participants
|
41.5 mg/dL
n=206 Participants
|
|
MDS TBR Index Vessel
|
2.46 ratio
n=99 Participants
|
2.41 ratio
n=107 Participants
|
2.44 ratio
n=206 Participants
|
|
TMNMX MDS
LCC - left common carotid
|
2.04 ratio
n=99 Participants
|
2.12 ratio
n=107 Participants
|
2.08 ratio
n=206 Participants
|
|
TMNMX MDS
RCC - right common carotid
|
2.12 ratio
n=99 Participants
|
2.13 ratio
n=107 Participants
|
2.12 ratio
n=206 Participants
|
|
TMNMX MDS
ATA - ascending thoracic aorta
|
2.45 ratio
n=99 Participants
|
2.22 ratio
n=107 Participants
|
2.34 ratio
n=206 Participants
|
|
TMNMX
Combined Carotid
|
1.93 ratio
n=99 Participants
|
1.93 ratio
n=107 Participants
|
1.93 ratio
n=206 Participants
|
|
TMNMX
ATA
|
2.34 ratio
n=99 Participants
|
2.12 ratio
n=107 Participants
|
2.23 ratio
n=206 Participants
|
|
SMNMX
Combined Carotid
|
1.82 ratio
n=99 Participants
|
1.78 ratio
n=107 Participants
|
1.80 ratio
n=206 Participants
|
|
SMNMX
ATA
|
2.26 ratio
n=99 Participants
|
2.24 ratio
n=107 Participants
|
2.25 ratio
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 monthsChange in arterial inflammation - The relative change at 8 months as compared to baseline in arterial inflammation as measured by the most diseased segment (MDS) of the index vessel. The MDS is defined as the 1.5 cm segment within the carotid artery (right or left carotid) that demonstrates the highest PET/CT activity, and is calculated as a mean of maximum TBR values derived from 3 contiguous axial segments. The index vessel in turn is defined as the vessel (either aorta, right, or left carotid) with the greatest mean TBR at baseline. (MDS TBR Index Vessel)
Outcome measures
| Measure |
Low Dose Methotrexate
n=26 Participants
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
n=27 Participants
matching placebo
|
|---|---|---|
|
Change in Arterial Inflammation
|
0.03 percent change
Interval -0.19 to 0.3
|
0.20 percent change
Interval -0.06 to 0.42
|
SECONDARY outcome
Timeframe: baseline and 8 monthsChange in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid) at follow up imaging as compared to baseline.
Outcome measures
| Measure |
Low Dose Methotrexate
n=26 Participants
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
n=27 Participants
matching placebo
|
|---|---|---|
|
Change in Max Target-to-background (TBR)
|
0.06 ratio
Interval -0.08 to 0.21
|
0.02 ratio
Interval -0.2 to 0.15
|
SECONDARY outcome
Timeframe: baseline and 8 monthsChange in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid)
Outcome measures
| Measure |
Low Dose Methotrexate
n=26 Participants
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
n=27 Participants
matching placebo
|
|---|---|---|
|
Change in Max TBR Within the Carotid Arteries
|
-0.04 ratio
Interval -0.29 to 0.12
|
0.06 ratio
Interval -0.14 to 0.2
|
Adverse Events
Low Dose Methotrexate
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Methotrexate
n=60 participants at risk
Low dose methotrexate - average dose of 15-20 mg po/weekly. will additionally receive 1 mg daily oral folate.
|
Placebo
n=63 participants at risk
matching placebo
|
|---|---|---|
|
Investigations
Missinjected dose (isotope)
|
1.7%
1/60 • 8 months
|
1.6%
1/63 • 8 months
|
Additional Information
Zahi Fayad, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60