Trial · NCT01756833
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
NCT01756833, Phase 2, Completed, University of Maryland, Baltimore; results first posted 2021-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial. Trials, record NCT01756833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01756833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
- NCT number
- NCT01756833
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 261 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Aneurysm
- Interventions
- Doxycycline, Placebo
- First posted
- 2012-12-28
- Last updated
- 2021-11-26
- Results first posted
- 2021-11-26
- Limitations and caveats
- Follow-up was limited to two years for most patients and results could differ with longer term follow-up.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization). | Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years). | Diameters were ranked from smallest to largest. Worse ranks were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and worst ranks were assigned to patients who died (in order likewise). Each rank was converted to a z-score corresponding to the value on the standard normal curve of its percentile. The primary analysis was based on linear regression of the change in z-scores from baseline to 2 years. Independent variables were baseline z-score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline). Missing values were multiply imputed. Higher score corresponds to less favorable outcome. There is no scale associated with these z-scores; the absolute z-scores have no biological meaning or clinically relevant threshold. A z-score of 0 corresponds to the median rank. The maximum and minimum z-scores are +2.41 and -2.41. See References in Protocol Section. |
| Secondary | Maximum Transverse Diameter, cm | Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). | Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years. |
| Secondary | Volume, cm^3 | Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). | Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years. |
| Secondary | MMP-9, ng/ml | Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years). | Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years. Analysis of hs-CRP will be performed using an immunoturbidimetric latex agglutination method (K-assay \[KAI-60\], Kamiya Biomedical Co., Seattle, WA). |
| Secondary | CRP, mg/l | Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years). | Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years. Plasma MMP-9 concentrations will be measured by an ELISA, two-site sandwich method that is commercially available (R \& D Systems, Quantikine, DMP900). |
| Other | Number of Participants With Aneurysm Rupture | Two years | Clinically reported rupture events. |
| Other | Number of Participants With Surgical Intervention | Two years | Clinically reported aneurysm repair. |
| Other | Number of Participants Who Died | Two years | Clinically reported deaths. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization). | Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years). | The number of participants refers to the number for whom CT scans were available. | z-score | MEAN |
| SECONDARY | Maximum Transverse Diameter, cm | Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | cm | MEAN |
| SECONDARY | Volume, cm^3 | Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | cm^3 | MEAN |
| SECONDARY | MMP-9, ng/ml | Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | ng/ml | MEAN |
| SECONDARY | CRP, mg/l | Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | mg/l | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Aneurysm Rupture | Two years | Full analysis population. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Surgical Intervention | Two years | Full analysis population. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died | Two years | Full analysis population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization). | Doxycycline | 0.0262 | Standard Deviation 1.0 | z-score | |
Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization). | Placebo | -0.0258 | Standard Deviation 1.0 | z-score | |
| Maximum Transverse Diameter, cm | Doxycycline | Maximum Transverse Diameter, cm 6 months | 4.40 | Standard Deviation 0.44 | cm |
| Maximum Transverse Diameter, cm | Placebo | Maximum Transverse Diameter, cm 6 months | 4.40 | Standard Deviation 0.43 | cm |
| Maximum Transverse Diameter, cm | Doxycycline | Maximum Transverse Diameter, cm 1 year | 4.49 | Standard Deviation 0.48 | cm |
| Maximum Transverse Diameter, cm | Placebo | Maximum Transverse Diameter, cm 1 year | 4.48 | Standard Deviation 0.44 | cm |
| Maximum Transverse Diameter, cm | Doxycycline | Maximum Transverse Diameter, cm 2 year | 4.61 | Standard Deviation 0.52 | cm |
| Maximum Transverse Diameter, cm | Placebo | Maximum Transverse Diameter, cm 2 year | 4.61 | Standard Deviation 0.53 | cm |
| Maximum Transverse Diameter, cm | Doxycycline | Maximum Transverse Diameter, cm Baseline to 2 year change | 0.36 | Standard Deviation 0.21 | cm |
| Maximum Transverse Diameter, cm | Placebo | Maximum Transverse Diameter, cm Baseline to 2 year change | 0.36 | Standard Deviation 0.28 | cm |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline | 133 | |
| Overall Study | STARTED | Placebo | 128 | |
| Overall Study | COMPLETED | Doxycycline | 129 | |
| Overall Study | COMPLETED | Placebo | 125 | |
| Overall Study | NOT COMPLETED | Doxycycline | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Frequent joint pain | Musculoskeletal and connective tissue disorders | Doxycycline | 84 | 129 | 84 |
| other | Frequent joint pain | Musculoskeletal and connective tissue disorders | Placebo | 79 | 125 | 79 |
| other | Frequent gastric or intestinal upset | Gastrointestinal disorders | Doxycycline | 58 | 129 | 58 |
| other | Frequent gastric or intestinal upset | Gastrointestinal disorders | Placebo | 56 | 125 | 56 |
| other | Frequent bleeding or bruising | Blood and lymphatic system disorders | Doxycycline | 47 | 129 | 47 |
| other | Frequent bleeding or bruising | Blood and lymphatic system disorders | Placebo | 54 | 125 | 54 |
| other | Frequent spells of dizziness | General disorders | Doxycycline | 34 | 129 | 34 |
| other | Frequent spells of dizziness | General disorders | Placebo | 37 | 125 | 37 |
| other | Skin rash or hives | Skin and subcutaneous tissue disorders | Doxycycline | 41 | 129 | 41 |
| other | Skin rash or hives | Skin and subcutaneous tissue disorders | Placebo | 29 | 125 | 29 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxycycline | 3 | 129 |
| Total, all-cause mortality | Placebo | 4 | 125 |
| Total, other adverse events | Doxycycline | 121 | 129 |
| Total, other adverse events | Placebo | 111 | 125 |
| Total, serious adverse events | Doxycycline | 70 | 129 |
| Total, serious adverse events | Placebo | 71 | 125 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG037120 | Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA^3CT ) | TERRIN, MICHAEL L; BAXTER, BERNARD TIMOTHY; CURCI, JOHN A; MATSUMURA, JON STEVEN | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL INSTITUTE ON AGING | 2011 to 2017 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doxycycline vs Placebo: Number of Participants With Aneurysm Rupture | Trial comparisons |
| Doxycycline vs Placebo: Number of Participants Who Died | Trial comparisons |
| Doxycycline vs Placebo: Number of Participants With Surgical Intervention | Trial comparisons |
| Doxycycline vs Placebo: deaths from any cause | Trial comparisons |
| Doxycycline vs Placebo: serious adverse events | Trial 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.
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/NCT01756833
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