Trial Outcomes & Findings for Dipyridamole for Immune Activation in HIV (NCT NCT02121756)
NCT ID: NCT02121756
Last Updated: 2019-04-11
Results Overview
Change in plasma levels of sCD14 from baseline to week 12
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2019-04-11
Participant Flow
Participant milestones
| Measure |
ARM A: Dipyridamole for 24 Weeks
Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
ARM A: Dipyridamole for 24 Weeks
Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
Baseline characteristics by cohort
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=21 Participants
Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks, Then Dipyridamole for 12 Weeks
n=19 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
19 Participants
n=19 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
50.0 years
STANDARD_DEVIATION 6.9 • n=19 Participants
|
49.2 years
STANDARD_DEVIATION 9.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=21 Participants
|
4 Participants
n=19 Participants
|
5 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=21 Participants
|
15 Participants
n=19 Participants
|
35 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=21 Participants
|
19 Participants
n=19 Participants
|
37 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=21 Participants
|
6 Participants
n=19 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=21 Participants
|
13 Participants
n=19 Participants
|
28 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=21 Participants
|
19 Participants
n=19 Participants
|
40 Participants
n=40 Participants
|
|
sCD14 plasma levels
|
1634000.00 pg/ml
n=17 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
1754500.00 pg/ml
n=18 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
1695500.00 pg/ml
n=35 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
|
sCD163 plasma levels
|
478.81 ng/ml
n=17 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
528.09 ng/ml
n=18 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
525.49 ng/ml
n=35 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
|
IL-6 plasma levels
|
1.30 pg/ml
n=17 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
1.77 pg/ml
n=18 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
1.48 pg/ml
n=35 Participants • 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
Change in plasma levels of sCD14 from baseline to week 12
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12
|
244500.00 pg/ml
Interval -318792.0 to 479000.0
|
-58250.00 pg/ml
Interval -572567.5 to 287500.0
|
PRIMARY outcome
Timeframe: baseline to week 12Population: 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
Change in Plasma levels of sCD163 from baseline to week 12
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12
|
-6.19 ng/ml
Interval -78.04 to 25.93
|
5.42 ng/ml
Interval -38.33 to 88.33
|
PRIMARY outcome
Timeframe: baseline to week 12Population: 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.
Change in Plasma levels of IL-6 from baseline to week 12
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12
|
-0.02 pg/ml
Interval -0.36 to 0.86
|
-0.07 pg/ml
Interval -0.59 to 0.88
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to DP after week 12.
To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
|
-0.05 proportion of CD8+ T cells
Interval -0.15 to 0.0
|
0.00 proportion of CD8+ T cells
Interval -0.05 to 0.05
|
SECONDARY outcome
Timeframe: First 12 weeks of dipyridamole treatmentPopulation: All enrolled participants
Grade 2 or higher adverse events and treatment discontinuations
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=21 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=19 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
Grade 2 adverse events
|
12 Participants
|
10 Participants
|
|
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
Grade 3 adverse events
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
Treatment discontinuations
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
No Grade 2 or 3 AEs or treatment discontinuations
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to DP after week 12.
To assess whether Dipyridamole reduces the proportion of cycling CD4+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole
|
-0.15 proportion of cycling CD4+ T Cells
Interval -0.3 to -0.05
|
-0.05 proportion of cycling CD4+ T Cells
Interval -0.2 to 0.05
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to DP after week 12.
To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing HLA-DR and CD38 after 12 weeks of DP treatment to placebo.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
|
-0.25 proportion of CD4+ T cells
Interval -0.7 to 0.0
|
0.10 proportion of CD4+ T cells
Interval -0.65 to 0.55
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing HLA-DR and CD38 after 12 weeks of Dipyridamole treatment to placebo.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
|
-0.85 proportion of CD8+ T cells
Interval -2.35 to 0.3
|
0.25 proportion of CD8+ T cells
Interval -0.4 to 1.8
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo
|
0.00 proportion of CD4+ T cells
Interval -0.2 to 0.2
|
0.00 proportion of CD4+ T cells
Interval -0.05 to 0.1
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To assess whether Dipyridamole reduces the proportion of cycling CD8+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells
|
-0.20 proportion of cycling CD8+ T Cells
Interval -0.5 to 0.05
|
0.05 proportion of cycling CD8+ T Cells
Interval -0.2 to 0.2
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the levels of sTNFαR after 12 weeks of dipyridamole treatment to placebo
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=16 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Systemic Inflammatory Biomarkers: Change in the Levels of sTNFαR
|
-84.61 pg/ml
Interval -287.58 to 492.48
|
34.26 pg/ml
Interval -284.5 to 495.36
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the levels of TNFα after 12 weeks of dipyridamole treatment to placebo
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=16 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Systemic Inflammatory Biomarkers: Change in the Levels of TNFα
|
-152.31 pg/ml
Interval -1430.45 to 1874.43
|
123.88 pg/ml
Interval -625.73 to 963.73
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the levels of hsCRP after 12 weeks of dipyridamole treatment to placebo
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Systemic Inflammatory Biomarkers: Change in the Levels of hsCRP
|
-233.57 ng/dl
Interval -699.19 to 970.26
|
-750.35 ng/dl
Interval -4385.43 to 201.94
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.
To compare changes in the levels of D-dimer after 12 weeks of dipyridamole treatment to placebo
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=17 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=18 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Coagulation Biomarkers: Change in the Levels of D-dimer
|
45.86 mcg/ml
Interval -7.88 to 142.07
|
36.35 mcg/ml
Interval -15.44 to 187.07
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol, participants randomized to placebo were crossed over to DP after week 12.
To compare % change at tmax in brachial artery flow-mediated dilation (FMD) after 12 weeks of dipyridamole treatment to placebo
Outcome measures
| Measure |
ARM A: Dipyridamole for 24 Weeks
n=14 Participants
ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks
n=17 Participants
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|
|
Changes in Brachial Artery Flow-mediated Dilation (FMD)
|
0.1 percentage change at tmax
Standard Deviation 5.2
|
-1.1 percentage change at tmax
Standard Deviation 4.8
|
Adverse Events
ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ARM B: Placebo for 12 Weeks From Baseline to Week 12
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24
n=21 participants at risk
ARM A: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
|
ARM B: Placebo for 12 Weeks From Baseline to Week 12
n=19 participants at risk
ARM B: Summary of Adverse Events for all participants randomized to receive Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12
|
ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24
n=19 participants at risk
ARM B: Summary of Adverse Events for all participants randomized to receive Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
|
|---|---|---|---|
|
Gastrointestinal disorders
gastrointestinal
|
61.9%
13/21 • Number of events 49 • Baseline to Week 24
|
42.1%
8/19 • Number of events 16 • Baseline to Week 24
|
26.3%
5/19 • Number of events 18 • Baseline to Week 24
|
|
Nervous system disorders
Neurologic
|
61.9%
13/21 • Number of events 28 • Baseline to Week 24
|
26.3%
5/19 • Number of events 6 • Baseline to Week 24
|
31.6%
6/19 • Number of events 11 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
38.1%
8/21 • Number of events 13 • Baseline to Week 24
|
10.5%
2/19 • Number of events 3 • Baseline to Week 24
|
21.1%
4/19 • Number of events 4 • Baseline to Week 24
|
|
Cardiac disorders
cardiovascular
|
28.6%
6/21 • Number of events 12 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
15.8%
3/19 • Number of events 3 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
23.8%
5/21 • Number of events 7 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
26.3%
5/19 • Number of events 5 • Baseline to Week 24
|
|
Endocrine disorders
endocrine/metabolic
|
14.3%
3/21 • Number of events 4 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
|
Investigations
chemistries
|
9.5%
2/21 • Number of events 3 • Baseline to Week 24
|
10.5%
2/19 • Number of events 2 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
|
General disorders
systemic
|
19.0%
4/21 • Number of events 7 • Baseline to Week 24
|
10.5%
2/19 • Number of events 2 • Baseline to Week 24
|
10.5%
2/19 • Number of events 3 • Baseline to Week 24
|
|
Renal and urinary disorders
genitourinary
|
9.5%
2/21 • Number of events 2 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
dermatologic
|
19.0%
4/21 • Number of events 6 • Baseline to Week 24
|
10.5%
2/19 • Number of events 2 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
|
Investigations
hematologic
|
9.5%
2/21 • Number of events 2 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
|
Infections and infestations
infection
|
4.8%
1/21 • Number of events 1 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
|
Eye disorders
ocular/visual
|
4.8%
1/21 • Number of events 1 • Baseline to Week 24
|
5.3%
1/19 • Number of events 1 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
|
Psychiatric disorders
psychological/emotional
|
0.00%
0/21 • Baseline to Week 24
|
10.5%
2/19 • Number of events 2 • Baseline to Week 24
|
0.00%
0/19 • Baseline to Week 24
|
Additional Information
Sharon Riddler, MD
University of Pittsburgh Department of Medicine
Phone: 412-383-1675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place