Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG037120 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison to a placebo-treated control group.
N-TA^3CT is a randomized, double-blind, placebo-controlled test of the hypothesis that doxycycline 100 mg bid, will reduce the rate of increase of maximum transverse diameter of small (3.5-5.0 cm among men and 3.5 to 4.5 cm among women) abdominal aortic aneurysms. The primary outcome is abdominal aortic aneurysm (AAA) maximum transverse diameter determined by CT scans at two-year follow-up with allowance for baseline (pre-randomization) diameter. Based on an anticipated growth rate of 2.5 mm per year in the placebo group and the current threshold at which surgical intervention will be offered to trial participants, (5.5 cm in men, 5.0 cm in women), the upper limit of AAA size for inclusion has been set at 5.0 cm for men and 4.5 cm for women. Among these subjects, the threshold for repair would be exceeded only by those exhibiting persistent growth. Secondary outcomes will determine if doxycycline affects other measures, e.g., MMP-9 levels in plasma and whether these effects are related to aneurysm growth. Nineteen clinical sites have identified pools of over 1600 patients with small aneurysm who meet the proposed inclusion/exclusion criteria. Two hundred fifty-eight patients will be randomized to placebo or doxycycline and their aneurysms followed for change in diameter at six-month intervals using CT imaging. The alternative hypothesis is that doxycycline will inhibit the expansion rate by 40% during the two years of observation. Patients enrolling in N-TA^3CT must be able to give consent for their participation themselves and meet study eligibility criteria.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Active Comparator | 100 mg capsules, twice a day, for a period of two years. |
|
| Placebo | Placebo Comparator | 100 mg capsules, twice a day, for a period of two years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | 100 mg po bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Transverse Diameter, cm | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Aneurysm Rupture | Clinically reported rupture events. | Two years |
| Number of Participants With Surgical Intervention | Clinically reported aneurysm repair. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael L Terrin, MD | University of Maryland, Baltimore | Principal Investigator |
| Bernard T Baxter, MD | University of Nebraska | Principal Investigator |
| Jonathan Matsumura, MD | University of Wisconsin Medical Center | Principal Investigator |
| John Curci, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States | ||
| Carondelet Heart & Vascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27018941 | Background | Baxter BT, Matsumura J, Curci J, McBride R, Blackwelder WC, Liu X, Larson L, Terrin ML; N-TA(3)CT Investigators. Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA(3)CT): Design of a Phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm. Contemp Clin Trials. 2016 May;48:91-8. doi: 10.1016/j.cct.2016.03.008. Epub 2016 Mar 25. | |
| 32986071 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline | 100 mg capsules, twice a day, for a period of two years. Doxycycline: 100 mg po bid |
| FG001 | Placebo | 100 mg capsules, twice a day, for a period of two years. Placebo: capsule identical to the doxycycline capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2018 | Jul 15, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | capsule identical to the doxycycline capsule |
|
|
| Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). |
| Volume, cm^3 | 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. | Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years). |
| MMP-9, ng/ml | 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). | 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). |
| CRP, mg/l | 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). | 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). |
| Two years |
| Number of Participants Who Died | Clinically reported deaths. | Two years |
| Tucson |
| Arizona |
| 85745 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Miami Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| University of South Florida Health Center | Tampa | Florida | 33606 | United States |
| Northwestern University Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| McLaren Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Omaha VAMC | Omaha | Nebraska | 68198 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Portland VAMC | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75216 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Utah VAMC | Salt Lake City | Utah | 84132 | United States |
| Lachin JM. Worst-Rank Score Methods-A Nonparametric Approach to Informatively Missing Data. JAMA. 2020 Oct 27;324(16):1670-1671. doi: 10.1001/jama.2020.7709. No abstract available. |
| 32453350 | Background | Lachin JM. Nonparametric Statistical Analysis. JAMA. 2020 May 26;323(20):2080-2081. doi: 10.1001/jama.2020.5874. No abstract available. |
| 32453369 | Result | Baxter BT, Matsumura J, Curci JA, McBride R, Larson L, Blackwelder W, Lam D, Wijesinha M, Terrin M; N-TA3CT Investigators. Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA. 2020 May 26;323(20):2029-2038. doi: 10.1001/jama.2020.5230. |
| 34655683 | Derived | Olson SL, Panthofer AM, Blackwelder W, Terrin ML, Curci JA, Baxter BT, Weaver FA, Matsumura JS; Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial Investigators. Role of volume in small abdominal aortic aneurysm surveillance. J Vasc Surg. 2022 Apr;75(4):1260-1267.e3. doi: 10.1016/j.jvs.2021.09.046. Epub 2021 Oct 14. |
| 33957227 | Derived | Panthofer AM, Olson SL, Rademacher BL, Grudzinski JK, Chaikof EL, Matsumura JS; N-TA(3)CT Investigators. Anatomic eligibility for endovascular aneurysm repair preserved over 2 years of surveillance. J Vasc Surg. 2021 Nov;74(5):1527-1536.e1. doi: 10.1016/j.jvs.2021.04.044. Epub 2021 May 4. |
| 33595625 | Derived | Olson SL, Wijesinha MA, Panthofer AM, Blackwelder WC, Upchurch GR Jr, Terrin ML, Curci JA, Baxter BT, Matsumura JS. Evaluating Growth Patterns of Abdominal Aortic Aneurysm Diameter With Serial Computed Tomography Surveillance. JAMA Surg. 2021 Apr 1;156(4):363-370. doi: 10.1001/jamasurg.2020.7190. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Seven participants who were randomized had insufficient follow-up to be included in the primary analysis. There were two patients whose baseline specimens were lost in shipment reducing the total number for baseline evaluations of MMP-9 and CRP from 254 to 252.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline | 100 mg capsules, twice a day, for a period of two years. Doxycycline: 100 mg po bid |
| BG001 | Placebo | 100 mg capsules, twice a day, for a period of two years. Placebo: capsule identical to the doxycycline capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||
| Clinical History | Count of Participants | Participants |
| ||||||||||||||||
| Medications | Count of Participants | Participants |
| ||||||||||||||||
| Aneurysm Diameter (Overall) | Aneurysm values round to 4.3 cm (SD = 0.4 cm) for the total and for each of the two treatment groups. | Mean | Standard Deviation | cm |
| ||||||||||||||
| Aneurysm Diameter (Men) | Aneurysm diameter (cm) measured in men | Mean | Standard Deviation | cm |
| ||||||||||||||
| Aneurysm Diameter (Women) | Aneurysm diameter (cm) measured in women | Mean | Standard Deviation | cm |
| ||||||||||||||
| Aneurysm Volume (Overall) | Mean | Standard Deviation | cm^3 |
| |||||||||||||||
| Aneurysm Volume (Men) | Aneurysm volume (cm3) measured in men | Mean | Standard Deviation | cm^3 |
| ||||||||||||||
| Aneurysm Volume (Women) | Aneurysm volume (cm3) measured in women | Mean | Standard Deviation | cm^3 |
| ||||||||||||||
| MMP-9 Levels (ng/ml) | MMP-9 levels (ng/ml) measured at baseline | Mean | Standard Deviation | ng/ml |
| ||||||||||||||
| CRP Levels, mg/l | CRP Levels (mg/l) measured at baseline | Mean | Standard Deviation | mg/l |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | The number of participants refers to the number for whom CT scans were available. | Posted | Mean | Standard Deviation | z-score | Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years). |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Transverse Diameter, cm | 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. | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | Posted | Mean | Standard Deviation | 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 | Volume, cm^3 | 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. | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | Posted | Mean | Standard Deviation | 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 | MMP-9, ng/ml | 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). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | Posted | Mean | Standard Deviation | 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 | CRP, mg/l | 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). | All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained. | Posted | Mean | Standard Deviation | 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). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Aneurysm Rupture | Clinically reported rupture events. | Full analysis population. | Posted | Count of Participants | Participants | Two years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Surgical Intervention | Clinically reported aneurysm repair. | Full analysis population. | Posted | Count of Participants | Participants | Two years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Died | Clinically reported deaths. | Full analysis population. | Posted | Count of Participants | Participants | Two years |
|
|
Two years
Adverse Events were classified without regard to specific Adverse Event Term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxycycline | 100 mg capsules, twice a day, for a period of two years. Doxycycline: 100 mg po bid | 3 | 129 | 70 | 129 | 121 | 129 |
| EG001 | Placebo | 100 mg capsules, twice a day, for a period of two years. Placebo: capsule identical to the doxycycline capsule | 4 | 125 | 71 | 125 | 111 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious or Unexpected Adverse Events | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Social circumstances | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serious or Unexpected Adverse Events | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Frequent joint pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Frequent gastric or intestinal upset | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Frequent bleeding or bruising | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Frequent spells of dizziness | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Skin rash or hives | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Moderate to severe sunburn | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Frequent headaches | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tooth discoloration | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Other symptom requiring study drug dose adjustment or discontinuation | General disorders | MedDRA (10.0) | Systematic Assessment |
|
Follow-up was limited to two years for most patients and results could differ with longer term follow-up.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael L. Terrin, MDCM, MPH, Contact Principal Investigator | University of Maryland School of Medicine | 410-706-6139 | mterrin@som.umaryland.edu |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2017 | Dec 19, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2015 | Jul 15, 2021 | ICF_004.pdf |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
| Coronary artery disease |
|
|
| Cancer |
|
|
| Chronic obstructive pulmonary disease |
|
|
| Diabetes |
|
|
| Family history of abdominal aortic aneurysm |
|
|
| Atrial fibrillation |
|
|
| Stroke |
|
|
| Congestive Heart Failure |
|
|
|
| Any antihypertensive |
|
|
| B-Blocker |
|
|
| Diuretics |
|
|
| Angiotensin-converting enzyme inhibitor |
|
|
| Calcium channel blocker |
|
|
| Angiotensin receptor blocker |
|
|
| Aspirin or other antiplatelet |
|
|
| Daily aspirin |
|
|
| Other antiplatelet |
|
|
|
|
|
|
|
|
|
|
| Superiority |
For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline). |
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|