Trial Outcomes & Findings for Anti-Platelets in Chronic Obstructive Pulmonary Disease (NCT NCT05567562)
NCT ID: NCT05567562
Last Updated: 2026-05-14
Results Overview
Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
After 2 weeks of therapy
Results posted on
2026-05-14
Participant Flow
15
10 COPD cases, 5 controls
Participant milestones
| Measure |
COPD Cases: On Dual Antiplatelet Therapy First
Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
|
COPD Cases: On Placebo First
Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
|
Controls: On Dual Antiplatelet Therapy First
Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
|
Controls: On Placebo First
Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
3
|
2
|
|
Overall Study
COMPLETED
|
5
|
5
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Platelets in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Total
n=15 Participants
Total of all reporting groups
|
COPD Cases: Dual Anti-platelet Therapy First, Then Placebo
n=5 Participants
Dual anti-platelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
|
COPD Cases: Placebo First, Then Dual Anti-platelet Therapy
n=5 Participants
Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual anti-platelet therapy
|
Controls: Dual Anti-platelet Therapy First, Then Placebo
n=3 Participants
Dual anti-platelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
|
Controls: Placebo First, Then Dual Anti-platelet Therapy
n=2 Participants
Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual anti-platelet therapy
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 6.4 • n=97 Participants
|
69.0 years
STANDARD_DEVIATION 2.6 • n=1512 Participants
|
69.2 years
STANDARD_DEVIATION 5.4 • n=504 Participants
|
64.3 years
STANDARD_DEVIATION 9.5 • n=2016 Participants
|
57.2 years
STANDARD_DEVIATION 0.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=97 Participants
|
2 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=97 Participants
|
3 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=97 Participants
|
5 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=97 Participants
|
2 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=97 Participants
|
3 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=97 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
ppFEV1
|
83.8 %
STANDARD_DEVIATION 23.0 • n=97 Participants
|
63.1 %
STANDARD_DEVIATION 11.1 • n=1512 Participants
|
79.7 %
STANDARD_DEVIATION 17.4 • n=504 Participants
|
108.0 %
STANDARD_DEVIATION 12.7 • n=2016 Participants
|
109.8 %
STANDARD_DEVIATION 8.1 • n=99 Participants
|
PRIMARY outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) All subjects comparing the outcome measures on and off treatment (N=14), 2) COPD subjects comparing the outcome measures on and off treatment (N=10), and 3) Control subjects comparing the outcome measures on and off treatment (N=4).
Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Pulmonary Microvascular Blood Volume, CV
|
0.89 CV
Standard Deviation 0.079
|
0.88 CV
Standard Deviation 0.072
|
0.92 CV
Standard Deviation 0.064
|
0.91 CV
Standard Deviation 0.052
|
0.81 CV
Standard Deviation 0.051
|
0.80 CV
Standard Deviation 0.042
|
SECONDARY outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual anti-platelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10) and 3) only controls comparing the same measures (N=4)
Pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Pulmonary Microvascular Blood Volume
|
602.8 Pulmonary microvascular blood volume, ml
Standard Deviation 206.1
|
595.0 Pulmonary microvascular blood volume, ml
Standard Deviation 177.8
|
581.7 Pulmonary microvascular blood volume, ml
Standard Deviation 216.8
|
592.9 Pulmonary microvascular blood volume, ml
Standard Deviation 196.3
|
655.5 Pulmonary microvascular blood volume, ml
Standard Deviation 194.7
|
600.2 Pulmonary microvascular blood volume, ml
Standard Deviation 146.3
|
SECONDARY outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10), and 3) only controls comparing the same measures (N=4)
Resting oxygen saturation
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Oxygen Saturation
|
95.64 oxygen saturation, %
Standard Deviation 2.34
|
95.71 oxygen saturation, %
Standard Deviation 1.94
|
94.9 oxygen saturation, %
Standard Deviation 2.33
|
95.5 oxygen saturation, %
Standard Deviation 2.27
|
97.5 oxygen saturation, %
Standard Deviation 1.0
|
96.25 oxygen saturation, %
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10), and 3) only control subjects comparing the same measures (N=4)
Small vessel volume (vessels \<5mm2 in CSA) as a percent of total lung volume, measured on non-contrast inspiratory CT
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Small Vessel Fraction on CT
|
14.6 small artery voxels/ml lung
Standard Deviation 2.38
|
15.2 small artery voxels/ml lung
Standard Deviation 2.60
|
14.1 small artery voxels/ml lung
Standard Deviation 2.6
|
14.7 small artery voxels/ml lung
Standard Deviation 2.4
|
15.8 small artery voxels/ml lung
Standard Deviation 1.5
|
16.5 small artery voxels/ml lung
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10) and 3) only control subjects comparing the same measures (N=4).
Percent of lung below -950HU on non-contrast inspiratory CT
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Percent Emphysema on CT
|
8.7 percent emphysema -950, %
Standard Deviation 7.6
|
8.3 percent emphysema -950, %
Standard Deviation 7.4
|
11.4 percent emphysema -950, %
Standard Deviation 7.4
|
10.8 percent emphysema -950, %
Standard Deviation 7.4
|
2.1 percent emphysema -950, %
Standard Deviation 1.6
|
2.3 percent emphysema -950, %
Standard Deviation 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=11), 2) only the COPD subjects comparing the same measures (N=8), and 3) only control subjects comparing the same measures (N=3). There were 3 missing expiratory CT scans (2 COPD subjects and 1 control).
Percentage of lung volume with attenuation \<-856HU on expiratory CT
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=11 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=11 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=8 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=8 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=3 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=3 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Air Trapping on Expiratory CT
|
28.4 % air trapping
Standard Deviation 22.9
|
28.3 % air trapping
Standard Deviation 22.8
|
36.6 % air trapping
Standard Deviation 21.4
|
35.8 % air trapping
Standard Deviation 22.1
|
6.3 % air trapping
Standard Deviation 4.2
|
8.1 % air trapping
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10), and 3) only controls comparing the same measures (N=4).
Forced expiratory volume in 1 second, post-bronchodilator
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
Post-BD FEV1
|
2.270 L
Standard Deviation 0.915
|
2.281 L
Standard Deviation 0.917
|
1.740 L
Standard Deviation 0.739
|
1.700 L
Standard Deviation 0.765
|
3.205 L
Standard Deviation 0.495
|
3.230 L
Standard Deviation 0.444
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPlatelet activation measures by flow cytometry: circulating monocyte-platelet aggregates (unstimulated), activated GPIIb/IIIa receptor, unstimulated, and stimulated by low and high dose arachidonic acid and adenosine diphosphate, and P-selectin on the platelet surface, unstimulated, and stimulated by low and high dose arachidonic acid and adenosine diphosphate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After 2 weeks of therapyPopulation: This is a crossover study and each participant received each treatment. The analyses presented are 1) all subject measures from visit after dual antiplatelet therapy compared to visit after placebo (N=14), 2) only the COPD subjects comparing the same measures (N=10) and 3) only control subjects comparing the same measures (N=4).
Fraction of exhaled nitric oxide
Outcome measures
| Measure |
On Dual Anti-platelet Therapy
n=14 Participants
On dual anti-platelet therapy, all subjects together
|
On Placebo
n=14 Participants
On placebo, all subjects together
|
On Dual Anti-platelet Therapy, COPD
n=10 Participants
On dual anti-platelet therapy, only those with COPD
|
On Placebo, COPD
n=10 Participants
On placebo, only those with COPD
|
On Dual Anti-platelet Therapy, Controls
n=4 Participants
Controls only, on dual anti-platelet therapy
|
On Placebo, Controls
n=4 Participants
Controls only, on placebo
|
|---|---|---|---|---|---|---|
|
FeNO
|
18.9 ppb
Standard Deviation 11.0
|
17.1 ppb
Standard Deviation 8.3
|
16.4 ppb
Standard Deviation 8.2
|
14.3 ppb
Standard Deviation 5.7
|
23.8 ppb
Standard Deviation 17.2
|
19.0 ppb
Standard Deviation 9.4
|
Adverse Events
COPD on Dual Anti-platelet Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
COPD on Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Subjects on Dual Anti-platelet Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Subjects on Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
COPD on Dual Anti-platelet Therapy
n=10 participants at risk
COPD subjects on aspirin and clopidogrel
|
COPD on Placebo
n=10 participants at risk
COPD subjects on placebo
|
Control Subjects on Dual Anti-platelet Therapy
n=4 participants at risk
All controls subjects on aspirin and clopidogrel
|
Control Subjects on Placebo
n=5 participants at risk
All controls subjects on placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Bruising
|
10.0%
1/10 • Number of events 1 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/10 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
25.0%
1/4 • Number of events 1 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/5 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
|
Blood and lymphatic system disorders
Expistaxis
|
10.0%
1/10 • Number of events 1 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/10 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/4 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/5 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltrate on CT
|
30.0%
3/10 • Number of events 3 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
20.0%
2/10 • Number of events 2 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
25.0%
1/4 • Number of events 1 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
0.00%
0/5 • Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks
One of the control subjects dropped out and did not get any dual anti-platelet therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place