Trial Outcomes & Findings for Inflammation and Coronary Endothelial Function (NCT NCT02366091)
NCT ID: NCT02366091
Last Updated: 2021-10-21
Results Overview
Coronary segment endothelial function, measured by MRI as the percent change in coronary cross sectional area (CSA) from rest to that during isometric handgrip exercise (IHE) (as % rest) at 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
At 8 weeks
Results posted on
2021-10-21
Participant Flow
17 enrolled participants were excluded from the study prior to randomization as follows: 9 did not qualify by screening MRI; 3 did not qualify by lab work; 3 declined to proceed after qualifying by MRI; 2 were not randomized as enrollment target was met.
Participant milestones
| Measure |
Methotrexate
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
3
|
1
|
|
Overall Study
STARTED
|
24
|
23
|
24
|
23
|
|
Overall Study
COMPLETED
|
21
|
16
|
21
|
22
|
Reasons for withdrawal
| Measure |
Methotrexate
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
3
|
1
|
Baseline Characteristics
Inflammation and Coronary Endothelial Function
Baseline characteristics by cohort
| Measure |
Methotrexate
n=24 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=23 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=24 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=23 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.6 Years
n=5 Participants
|
66.8 Years
n=7 Participants
|
63.4 Years
n=5 Participants
|
63.9 Years
n=4 Participants
|
63.77 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksCoronary segment endothelial function, measured by MRI as the percent change in coronary cross sectional area (CSA) from rest to that during isometric handgrip exercise (IHE) (as % rest) at 8 weeks.
Outcome measures
| Measure |
Methotrexate
n=21 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=16 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=21 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=22 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Percent Change in Coronary Cross Sectional Area (CSA) From Rest to That During Isometric Handgrip Exercise (IHE)
|
-1.70 Percent change from rest measurement
Standard Error 2.85
|
2.71 Percent change from rest measurement
Standard Error 3.74
|
-0.39 Percent change from rest measurement
Standard Error 2.23
|
2.04 Percent change from rest measurement
Standard Error 2.05
|
SECONDARY outcome
Timeframe: At 24 weeksPopulation: Not all participants who completed the primary outcome at 8 weeks went on to complete the 24 week studies, resulting in different numbers of participants analyzed between weeks 8 and 24.
Change in coronary segment endothelial function, measured by MRI as the percent change in coronary cross sectional area (CSA) from rest to that during isometric handgrip exercise (IHE) (as % rest) at 24 weeks.
Outcome measures
| Measure |
Methotrexate
n=18 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=12 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=17 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=20 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Percent Change in Coronary Cross Sectional Area (CSA) From Rest to That During Isometric Handgrip Exercise (IHE)
|
1.94 Percent change from rest measurement
Standard Error 3.36
|
-5.39 Percent change from rest measurement
Standard Error 3.91
|
2.64 Percent change from rest measurement
Standard Error 2.60
|
9.26 Percent change from rest measurement
Standard Error 2.91
|
SECONDARY outcome
Timeframe: At 8 weeksChange in coronary blood flow (CBF), measured by MRI as the percent change from rest to IHE stress (as % rest) at 8 weeks.
Outcome measures
| Measure |
Methotrexate
n=21 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=16 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=21 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=22 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Percent Change in Coronary Blood Flow (CBF), Measured by MRI as the Change From Rest to IHE Stress
|
10.23 Percent change from rest measurement
Standard Error 4.70
|
14.06 Percent change from rest measurement
Standard Error 4.57
|
12.38 Percent change from rest measurement
Standard Error 5.58
|
13.81 Percent change from rest measurement
Standard Error 4.68
|
SECONDARY outcome
Timeframe: At 8 weeksSerum high-sensitivity C reactive protein (hs-CRP), measured by laboratory assessment in mg/l at 8 weeks.
Outcome measures
| Measure |
Methotrexate
n=21 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=16 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=21 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=22 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Serum High-sensitivity C Reactive Protein (Hs-CRP)
|
2.40 mg/l
Standard Error 0.54
|
3.10 mg/l
Standard Error 1.68
|
1.45 mg/l
Standard Error 0.22
|
1.65 mg/l
Standard Error 0.39
|
SECONDARY outcome
Timeframe: At 8 weeksSerum interleukin-6 (IL-6), measured by laboratory assessment in pg/ml at 8 weeks.
Outcome measures
| Measure |
Methotrexate
n=21 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=16 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=21 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=22 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Serum Interleukin-6 (IL-6)
|
1.61 pg/ml
Standard Error 0.55
|
1.20 pg/ml
Standard Error 0.27
|
0.83 pg/ml
Standard Error 0.07
|
0.92 pg/ml
Standard Error 0.07
|
SECONDARY outcome
Timeframe: At 8 weeksBrachial flow mediated dilation (FMD), measured as percent brachial artery dilation by ultrasound at 8 weeks.
Outcome measures
| Measure |
Methotrexate
n=21 Participants
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=16 Participants
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=21 Participants
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=22 Participants
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Brachial Flow Mediated Dilation (FMD)
|
4.37 percent brachial artery dilation
Standard Error 0.70
|
3.23 percent brachial artery dilation
Standard Error 0.52
|
3.58 percent brachial artery dilation
Standard Error 0.48
|
4.57 percent brachial artery dilation
Standard Error 0.60
|
Adverse Events
Methotrexate
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Colchicine
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Methotrexate & Colchicine
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methotrexate
n=24 participants at risk
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=23 participants at risk
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=24 participants at risk
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=23 participants at risk
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Eye disorders
Hopsitalization
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
Other adverse events
| Measure |
Methotrexate
n=24 participants at risk
Methotrexate 15 mg weekly by mouth and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Colchicine
n=23 participants at risk
Colchicine 0.6 mg daily by mouth and placebo for methotrexate 1 tablet weekly by mouth and folate 1 mg by mouth daily
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
Methotrexate & Colchicine
n=24 participants at risk
Methotrexate 15 mg by mouth weekly and colchicine 0.6 mg by mouth daily and folate 1 mg by mouth daily
Methotrexate: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=23 participants at risk
Placebo for methotrexate 1 tablet by mouth weekly and placebo for colchicine 1 tablet by mouth daily and folate 1 mg by mouth daily
Placebo: Prepared by Johns Hopkins Investigational Drug Service to mimic methotrexate and colchicine.
|
|---|---|---|---|---|
|
Infections and infestations
Infection
|
33.3%
8/24 • Number of events 8 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
34.8%
8/23 • Number of events 8 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
37.5%
9/24 • Number of events 9 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
26.1%
6/23 • Number of events 6 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
37.5%
9/24 • Number of events 9 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
39.1%
9/23 • Number of events 9 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
29.2%
7/24 • Number of events 7 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Musculoskeletal and connective tissue disorders
Joint/Muscle Soreness/Stiffness
|
20.8%
5/24 • Number of events 5 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
29.2%
7/24 • Number of events 7 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
30.4%
7/23 • Number of events 7 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Cardiac disorders
Chest Pain
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Blood and lymphatic system disorders
Extremity swelling
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Infections and infestations
Dental pain/infection
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Injury, poisoning and procedural complications
Physical Injury
|
16.7%
4/24 • Number of events 4 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Psychiatric disorders
Anxiety/Depression
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Hepatobiliary disorders
Increased Alanine Amino Trans
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Blood and lymphatic system disorders
Decreased White Blood Cell
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
13.0%
3/23 • Number of events 3 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Blood and lymphatic system disorders
Decreased Hematocrit
|
16.7%
4/24 • Number of events 4 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
26.1%
6/23 • Number of events 6 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
33.3%
8/24 • Number of events 8 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
26.1%
6/23 • Number of events 6 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Renal and urinary disorders
Decreased Estimated GFR
|
20.8%
5/24 • Number of events 5 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
17.4%
4/23 • Number of events 4 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
|
Hepatobiliary disorders
Increased Aspartate Amino Trans >3 x the normal range
|
0.00%
0/24 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
0.00%
0/23 • Adverse event data were collected over study enrollment and up to 4 weeks after the last dose of the study drug (total up to 28 weeks after initiation of study drug).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place