Trial Outcomes & Findings for Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV (NCT NCT02624180)
NCT ID: NCT02624180
Last Updated: 2021-10-21
Results Overview
Percent change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Difference between measurements at baseline compared to measurement at 8 weeks
Results posted on
2021-10-21
Participant Flow
Two participants randomized to colchicine withdrew before receiving study drug.
Participant milestones
| Measure |
Colchicine
Colchicine 0.6 mg daily by mouth
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 colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
38
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Baseline characteristics by cohort
| Measure |
Colchicine
n=43 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=38 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.66 Years
n=5 Participants
|
52.0 Years
n=7 Participants
|
54.25 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Difference between measurements at baseline compared to measurement at 8 weeksPercent change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 8 weeks.
Outcome measures
| Measure |
Colchicine
n=37 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=34 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Coronary Endothelial Function Measured by Percent Change in Coronary Blood Flow With Exercise (%) at 8 Weeks
|
8.1 Percent change from rest measurement
Standard Deviation 4.4
|
13.4 Percent change from rest measurement
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: At 24 weeks.Change in coronary blood flow (CBF) from rest to that during isometric handgrip exercise (IHE) stress at 24 weeks.
Outcome measures
| Measure |
Colchicine
n=34 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=32 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Coronary Endothelial Function at 24 Weeks;
|
-1.27 Percent change from rest measurement
Interval -11.56 to 20.35
|
16.60 Percent change from rest measurement
Interval -2.04 to 29.66
|
SECONDARY outcome
Timeframe: Difference between measurements at baseline compared to measurement at 8 weeksChange in CSA as measured by the difference between CSA at rest and under IHE stress at 8 weeks
Outcome measures
| Measure |
Colchicine
n=37 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=34 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Change in Coronary Artery Cross-sectional Area (CSA) at 8 Weeks
|
-0.10 Percent change from baseline measurement
Interval -5.75 to 3.99
|
1.53 Percent change from baseline measurement
Interval -3.76 to 6.63
|
SECONDARY outcome
Timeframe: At 24 weeksChange in CSA as measured by the difference between CSA at rest and under IHE stress at 24 weeks
Outcome measures
| Measure |
Colchicine
n=34 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=33 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Change in Coronary Artery Cross-sectional Area (CSA) at 24 Weeks
|
-0.96 Percent change from rest measurement
Interval -5.86 to 6.61
|
5.04 Percent change from rest measurement
Interval -1.6 to 13.37
|
SECONDARY outcome
Timeframe: At 8 weeks.High-sensitivity C-reactive protein (hsCRP) at 8 weeks
Outcome measures
| Measure |
Colchicine
n=37 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=34 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
High-sensitivity C-reactive Protein (hsCRP) at 8 Weeks.
|
1.65 mg/l
Interval 0.77 to 4.67
|
1.26 mg/l
Interval 0.86 to 2.68
|
SECONDARY outcome
Timeframe: At 8 weeksBrachial flow mediated dilatation (FMD) at 8 weeks.
Outcome measures
| Measure |
Colchicine
n=37 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=34 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Brachial Flow Mediated Dilatation (FMD) at 8 Weeks.
|
4.26 % brachial artery dilation
Interval 1.76 to 6.17
|
4.12 % brachial artery dilation
Interval 2.09 to 6.16
|
SECONDARY outcome
Timeframe: At 8 weeksInterleukin-6 (IL-6) at 8 weeks
Outcome measures
| Measure |
Colchicine
n=37 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=34 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Interleukin-6 (IL-6) at 8 Weeks
|
0.53 pg/ml
Interval 0.43 to 0.81
|
0.64 pg/ml
Interval 0.42 to 0.85
|
SECONDARY outcome
Timeframe: At 24 weeksHigh-sensitivity C-reactive Protein (hsCRP) at 24 weeks
Outcome measures
| Measure |
Colchicine
n=35 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=32 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
High-sensitivity C-reactive Protein (hsCRP) at 24 Weeks
|
1.00 mg/l
Interval 0.5 to 3.2
|
1.30 mg/l
Interval 0.8 to 2.2
|
SECONDARY outcome
Timeframe: At 24 weeksBrachial Flow Mediated Dilatation (FMD) at 24 Weeks.
Outcome measures
| Measure |
Colchicine
n=30 Participants
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=30 Participants
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Brachial Flow Mediated Dilatation (FMD) at 24 Weeks.
|
3.82 % brachial artery dilation
Interval 2.25 to 7.25
|
3.46 % brachial artery dilation
Interval 1.41 to 8.29
|
Adverse Events
Colchicine
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Colchicine
n=41 participants at risk
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=38 participants at risk
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Renal and urinary disorders
Hospitalization
|
0.00%
0/41 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/41 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
Other adverse events
| Measure |
Colchicine
n=41 participants at risk
Colchicine 0.6 mg daily by mouth
Colchicine: Administered to determine the effect of anti-inflammatory agents on coronary and systemic endothelial function in patients with coronary artery disease.
|
Placebo
n=38 participants at risk
Placebo for colchicine 1 tablet by mouth daily
Placebo: A substance containing no medication
|
|---|---|---|
|
Infections and infestations
Infection
|
22.0%
9/41 • Number of events 9 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
50.0%
19/38 • Number of events 19 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
29.3%
12/41 • Number of events 12 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
23.7%
9/38 • Number of events 9 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Musculoskeletal and connective tissue disorders
Joint/Muscle Soreness/Stiffness
|
19.5%
8/41 • Number of events 8 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
23.7%
9/38 • Number of events 9 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
General disorders
Extremity swelling
|
0.00%
0/41 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
General disorders
Dental pain/infection
|
0.00%
0/41 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
7.9%
3/38 • Number of events 3 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
4.9%
2/41 • Number of events 2 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
13.2%
5/38 • Number of events 5 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Eye disorders
Vision
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
0.00%
0/38 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Injury, poisoning and procedural complications
Physical Injury
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
7.9%
3/38 • Number of events 3 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Hepatobiliary disorders
Increased Aspartate Amino Trans
|
17.1%
7/41 • Number of events 7 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
15.8%
6/38 • Number of events 6 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Hepatobiliary disorders
Increased Alanine Amino Trans
|
17.1%
7/41 • Number of events 7 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
13.2%
5/38 • Number of events 5 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Blood and lymphatic system disorders
Decreased White Blood Cell
|
17.1%
7/41 • Number of events 7 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
10.5%
4/38 • Number of events 4 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Blood and lymphatic system disorders
Decreased Hematocrit
|
24.4%
10/41 • Number of events 10 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
21.1%
8/38 • Number of events 8 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
|
Renal and urinary disorders
Decreased Estimated GFR
|
24.4%
10/41 • Number of events 10 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
18.4%
7/38 • Number of events 7 • Adverse event data were collected over study enrollment (up to 24 weeks after randomization to study drug)
Two participants randomized to colchicine withdrew before receiving study drug so number of participants at risk listed here as 41.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place