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Trial · NCT03008915

Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

NCT03008915, Phase 2, Completed, Columbia University; results first posted 2021-02-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency. Trials, record NCT03008915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03008915

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
NCT number
NCT03008915
Status
Completed
Phases
Phase 2
Enrollment
15 participants, actual
Lead sponsor
Columbia University
Conditions
Alpha-1 Antitrypsin Deficiency, Emphysema, Chronic Obstructive Pulmonary Disease
Interventions
Aspirin, Placebo, Withdrawal from alpha1 antitrypsin replacement therapy
First posted
2017-01-04
Last updated
2021-02-17
Results first posted
2021-02-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPulmonary Microvascular Blood Flow, Mean2 weeksPulmonary microvascular blood flow is measured on contrast-enhanced MRI, limited to blood flow in the 2cm periphery of the lung
SecondaryEndothelial Microparticles2 weeks
Endothelial microparticles (EMPs) are vesicles shed from endothelial plasma membranes into the circulation in response to endothelial cell perturbation. CD31+ is a measure of apoptotic endothelial microparticles, CD62+ (P-selectin) is a measure of endothelial activation, and Annexin V/CD31+ is a more specific marker of endothelial cell apoptosis.
SecondaryEndothelial Microparticles5 weeks
Endothelial microparticles (EMPs) are vesicles shed from endothelial plasma membranes into the circulation in response to endothelial cell perturbation. CD31+ is a measure of apoptotic endothelial microparticles, CD62+ (P-selectin) is a measure of endothelial activation, and Annexin V/CD31+ is a more specific marker of endothelial cell apoptosis.
SecondaryPulmonary Microvascular Blood Flow, Mean5 weeksPulmonary microvascular blood flow is measured on contrast-enhanced MRI in the peripheral 2cm of the lung.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPulmonary Microvascular Blood Flow, Mean2 weeks
Due to errors in acquisition of MRI, a number of participants had uninterpretable scans. 13 participants had MRIs interpretable for PMBF on placebo, and 7 on aspirin. Altogether, there were 6 participants with paired results from the two scans.
mL blood/minute per 100mL lungMEAN
SECONDARYEndothelial Microparticles2 weeksDue to lab closure and technician availability, only the first 3 participants had EMPs measured.EMPs/uLMEAN
SECONDARYEndothelial Microparticles5 weeksOnly 2 participants had EMPs measured on placebo and 2 off AAT replacement therapy, only 1 participant had EMPs measured at both time points.EMPs/uLMEAN
SECONDARYPulmonary Microvascular Blood Flow, Mean5 weeks
2 participants who completed the withdrawal phase had MRIs interpretable for PMBF on placebo and off AAT replacement therapy, data for the other 2 participants was uninterpretable for at least 1 of the 2 scans.
mL blood/minute per 100mL lungMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Pulmonary Microvascular Blood Flow, MeanAspirin36.9Standard Deviation 13.0mL blood/minute per 100mL lung
Pulmonary Microvascular Blood Flow, MeanPlacebo35.1Standard Deviation 15.4mL blood/minute per 100mL lung
Endothelial MicroparticlesAspirinCD31+749.0Standard Deviation 231.1EMPs/uL
Endothelial MicroparticlesPlaceboCD31+821.5Standard Deviation 3.5EMPs/uL
Endothelial MicroparticlesAspirinCD62+1357.3Standard Deviation 469.6EMPs/uL
Endothelial MicroparticlesPlaceboCD62+596Standard Deviation 287.1EMPs/uL
Endothelial MicroparticlesAspirinAnnexin V, CD31+145.0Standard Deviation 62.8EMPs/uL
Endothelial MicroparticlesPlaceboAnnexin V, CD31+317.0Standard Deviation 210.7EMPs/uL
Endothelial MicroparticlesOff Alpha-1 Replacement TherapyCD31+996.0Standard Deviation 408.7EMPs/uL
Endothelial MicroparticlesPlaceboCD31+821.5Standard Deviation 3.5EMPs/uL

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Treatment 1STARTEDAspirin First, Then Placebo8
Treatment 1STARTEDPlacebo First, Then Aspirin7
Treatment 1COMPLETEDAspirin First, Then Placebo8
Treatment 1COMPLETEDPlacebo First, Then Aspirin6
Treatment 1NOT COMPLETEDAspirin First, Then Placebo0
Treatment 1NOT COMPLETEDPlacebo First, Then Aspirin1
Treatment 2STARTEDAspirin First, Then Placebo8
Treatment 2STARTEDPlacebo First, Then Aspirin6
Treatment 2COMPLETEDAspirin First, Then Placebo8
Treatment 2COMPLETEDPlacebo First, Then Aspirin6

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherSyncopeVascular disordersAspirin0140
otherSyncopeVascular disordersPlacebo1151

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAspirin014
Total, all-cause mortalityPlacebo015
Total, other adverse eventsAspirin014
Total, other adverse eventsPlacebo115
Total, serious adverse eventsAspirin014
Total, serious adverse eventsPlacebo015

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Aspirin vs Placebo: deaths from any causeTrial comparisons
Aspirin vs Placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03008915

GET https://conductscience.org/api/trials/v1/NCT03008915/registered