Aneurysm
Conditions
Keywords
abdominal, aortic, aneurysm
Brief summary
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.
Detailed description
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.
Interventions
DRUGDoxycycline
100 mg po bid
DRUGPlacebo
capsule identical to the doxycycline capsule
Sponsors
National Institute on Aging (NIA)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 55 years of age or older, women post-surgical menopause or at least two years since last menses if natural menopause. * CT scan documented infrarenal abdominal aortic aneurysm with maximum transverse diameter larger than 35 mm and no greater than 50 mm, in men, and larger than 35 mm and no greater than 45 mm in women.
Exclusion criteria
* Patients will be excluded from the study if they are unable to give their own informed consent to participate. * have symptoms related to abdominal aortic aneurysm. * have other intra-abdominal vascular pathology that may require repair within 24 months (e.g., renal artery stenosis, large iliac artery aneurysms, iliac occlusive disease, aneurysmal involvement of the renal artery). * have had previous abdominal aortic aneurysm repair by open surgical or endovascular technique. * have an active malignancy with life expectancy less than two years. * have an allergy to tetracycline. * are currently or have been recently treated (previous six months) with tetracycline derivatives. * they are currently taking anti-seizure medicines metabolized by pathways influenced by doxycycline (e.g., carbamazepine, phenytoin, and barbiturates). * stage II hypertension (patients whose blood pressure is persistently in the range of systolic \> 160 mm Hg or diastolic \> 100 mm Hg despite primary physician's best effort to achieve adequate therapy. * have dialysis dependent renal failure or impending dialysis treatment for renal insufficiency. * have a chronic infection requiring long-term (\> 2 weeks) antibiotics. * have known genetic syndromes responsible for the abdominal aortic aneurysm (e.g., Marfan's Syndrome). * are under treatment with systemic immunosuppressive agents. * could become pregnant. * are not good candidates for clinical trial participation. * are enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died | Two years | Clinically reported deaths. |
| Number of Participants With Surgical Intervention | Two years | Clinically reported aneurysm repair. |
| Number of Participants With Aneurysm Rupture | Two years | Clinically reported rupture events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline 100 mg capsules, twice a day, for a period of two years.
Doxycycline: 100 mg po bid | 129 |
| Placebo 100 mg capsules, twice a day, for a period of two years.
Placebo: capsule identical to the doxycycline capsule | 125 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Doxycycline | Placebo |
|---|---|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 7.4 | 71.0 years STANDARD_DEVIATION 7.5 | 70.9 years STANDARD_DEVIATION 7.3 |
| Aneurysm Diameter (Men) | 4.4 cm STANDARD_DEVIATION 0.4 | 4.3 cm STANDARD_DEVIATION 0.4 | 4.4 cm STANDARD_DEVIATION 0.4 |
| Aneurysm Diameter (Overall) | 4.3 cm STANDARD_DEVIATION 0.4 | 4.3 cm STANDARD_DEVIATION 0.4 | 4.3 cm STANDARD_DEVIATION 0.4 |
| Aneurysm Diameter (Women) | 4.0 cm STANDARD_DEVIATION 0.3 | 4.1 cm STANDARD_DEVIATION 0.3 | 3.9 cm STANDARD_DEVIATION 0.3 |
| Aneurysm Volume (Men) | 99.1 cm^3 STANDARD_DEVIATION 23.8 | 99.0 cm^3 STANDARD_DEVIATION 24.3 | 99.2 cm^3 STANDARD_DEVIATION 23.3 |
| Aneurysm Volume (Overall) | 96.4 cm^3 STANDARD_DEVIATION 24 | 97.0 cm^3 STANDARD_DEVIATION 24 | 95.8 cm^3 STANDARD_DEVIATION 24 |
| Aneurysm Volume (Women) | 79.6 cm^3 STANDARD_DEVIATION 16.7 | 84.9 cm^3 STANDARD_DEVIATION 18.5 | 74.3 cm^3 STANDARD_DEVIATION 15.9 |
| Clinical History Atrial fibrillation | 33 Participants | 16 Participants | 17 Participants |
| Clinical History Cancer | 82 Participants | 44 Participants | 38 Participants |
| Clinical History Chronic obstructive pulmonary disease | 59 Participants | 30 Participants | 29 Participants |
| Clinical History Congestive Heart Failure | 20 Participants | 11 Participants | 9 Participants |
| Clinical History Coronary artery disease | 104 Participants | 51 Participants | 53 Participants |
| Clinical History Diabetes | 57 Participants | 35 Participants | 22 Participants |
| Clinical History Family history of abdominal aortic aneurysm | 47 Participants | 27 Participants | 20 Participants |
| Clinical History Hypercholesterolemia | 196 Participants | 98 Participants | 98 Participants |
| Clinical History Stroke | 28 Participants | 13 Participants | 15 Participants |
| CRP Levels, mg/l | 4.5 mg/l STANDARD_DEVIATION 10.3 | 5.4 mg/l STANDARD_DEVIATION 13.6 | 3.6 mg/l STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 241 Participants | 122 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Medications Angiotensin-converting enzyme inhibitor | 88 Participants | 51 Participants | 37 Participants |
| Medications Angiotensin receptor blocker | 45 Participants | 20 Participants | 25 Participants |
| Medications Any antihypertensive | 199 Participants | 105 Participants | 94 Participants |
| Medications Aspirin or other antiplatelet | 187 Participants | 95 Participants | 92 Participants |
| Medications B-Blocker | 131 Participants | 68 Participants | 63 Participants |
| Medications Calcium channel blocker | 60 Participants | 26 Participants | 34 Participants |
| Medications Daily aspirin | 175 Participants | 86 Participants | 89 Participants |
| Medications Diuretics | 83 Participants | 43 Participants | 40 Participants |
| Medications Other antiplatelet | 44 Participants | 19 Participants | 25 Participants |
| Medications Statin | 207 Participants | 104 Participants | 103 Participants |
| MMP-9 Levels (ng/ml) | 54.8 ng/ml STANDARD_DEVIATION 52.1 | 54.6 ng/ml STANDARD_DEVIATION 53.2 | 55.0 ng/ml STANDARD_DEVIATION 51.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 233 Participants | 120 Participants | 113 Participants |
| Region of Enrollment United States | 254 participants | 129 participants | 125 participants |
| Sex: Female, Male Female | 35 Participants | 18 Participants | 17 Participants |
| Sex: Female, Male Male | 219 Participants | 111 Participants | 108 Participants |
| Smoking Status Current Smoker | 87 Participants | 44 Participants | 43 Participants |
| Smoking Status Former Smoker | 148 Participants | 75 Participants | 73 Participants |
| Smoking Status Never Smoked | 19 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 129 | 4 / 125 |
| other Total, other adverse events | 121 / 129 | 111 / 125 |
| serious Total, serious adverse events | 70 / 129 | 71 / 125 |
Outcome results
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.
Time frame: Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years).
Population: The number of participants refers to the number for whom CT scans were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | 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). | 0.0262 z-score | Standard Deviation 1 |
| Placebo | 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). | -0.0258 z-score | Standard Deviation 1 |
Comparison: Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level.p-value: 0.7195% CI: [-0.07, 0.07]ANCOVA on normal scores
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).
Time frame: 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).
Population: All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxycycline | CRP, mg/l | CRP, mg/l 6 months | 5.4 mg/l | Standard Deviation 12.7 |
| Doxycycline | CRP, mg/l | CRP, mg/l 1 year | 3.5 mg/l | Standard Deviation 4.8 |
| Doxycycline | CRP, mg/l | CRP, mg/l 1 year, 6 months | 3.5 mg/l | Standard Deviation 6.5 |
| Doxycycline | CRP, mg/l | CRP, mg/l 2 year | 5.9 mg/l | Standard Deviation 15.6 |
| Placebo | CRP, mg/l | CRP, mg/l 2 year | 4.0 mg/l | Standard Deviation 5.3 |
| Placebo | CRP, mg/l | CRP, mg/l 6 months | 4.5 mg/l | Standard Deviation 10.7 |
| Placebo | CRP, mg/l | CRP, mg/l 1 year, 6 months | 5.7 mg/l | Standard Deviation 15.1 |
| Placebo | CRP, mg/l | CRP, mg/l 1 year | 4.1 mg/l | Standard Deviation 6.9 |
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.
Time frame: Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).
Population: All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxycycline | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 6 months | 4.40 cm | Standard Deviation 0.44 |
| Doxycycline | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 1 year | 4.49 cm | Standard Deviation 0.48 |
| Doxycycline | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 2 year | 4.61 cm | Standard Deviation 0.52 |
| Doxycycline | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm Baseline to 2 year change | 0.36 cm | Standard Deviation 0.21 |
| Placebo | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm Baseline to 2 year change | 0.36 cm | Standard Deviation 0.28 |
| Placebo | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 6 months | 4.40 cm | Standard Deviation 0.43 |
| Placebo | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 2 year | 4.61 cm | Standard Deviation 0.53 |
| Placebo | Maximum Transverse Diameter, cm | Maximum Transverse Diameter, cm 1 year | 4.48 cm | Standard Deviation 0.44 |
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).
Time frame: 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).
Population: All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxycycline | MMP-9, ng/ml | MMP-9, ng/ml 6 months | 60.9 ng/ml | Standard Deviation 85.3 |
| Doxycycline | MMP-9, ng/ml | MMP-9, ng/ml 1 year | 63.0 ng/ml | Standard Deviation 90.1 |
| Doxycycline | MMP-9, ng/ml | MMP-9, ng/ml 1 year, 6 months | 48.8 ng/ml | Standard Deviation 43.9 |
| Doxycycline | MMP-9, ng/ml | MMP-9, ng/ml 2 year | 53.8 ng/ml | Standard Deviation 54.8 |
| Placebo | MMP-9, ng/ml | MMP-9, ng/ml 2 year | 52.8 ng/ml | Standard Deviation 41.9 |
| Placebo | MMP-9, ng/ml | MMP-9, ng/ml 6 months | 61.9 ng/ml | Standard Deviation 61.8 |
| Placebo | MMP-9, ng/ml | MMP-9, ng/ml 1 year, 6 months | 68.3 ng/ml | Standard Deviation 86.7 |
| Placebo | MMP-9, ng/ml | MMP-9, ng/ml 1 year | 61.0 ng/ml | Standard Deviation 91.5 |
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.
Time frame: Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).
Population: All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxycycline | Volume, cm^3 | Volume, cm^3 6 months | 102.90 cm^3 | Standard Deviation 26.19 |
| Doxycycline | Volume, cm^3 | Volume, cm^3 1 year | 106.00 cm^3 | Standard Deviation 29.13 |
| Doxycycline | Volume, cm^3 | Volume, cm^3 2 year | 113.60 cm^3 | Standard Deviation 34.91 |
| Doxycycline | Volume, cm^3 | Volume, cm^3 Baseline to 2 year change | 18.60 cm^3 | Standard Deviation 14.38 |
| Placebo | Volume, cm^3 | Volume, cm^3 Baseline to 2 year change | 19.16 cm^3 | Standard Deviation 15.75 |
| Placebo | Volume, cm^3 | Volume, cm^3 6 months | 100.40 cm^3 | Standard Deviation 26.27 |
| Placebo | Volume, cm^3 | Volume, cm^3 2 year | 111.20 cm^3 | Standard Deviation 33.14 |
| Placebo | Volume, cm^3 | Volume, cm^3 1 year | 105.00 cm^3 | Standard Deviation 28.28 |
Other Pre-specified
Number of Participants Who Died
Clinically reported deaths.
Time frame: Two years
Population: Full analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doxycycline | Number of Participants Who Died | 3 Participants |
| Placebo | Number of Participants Who Died | 4 Participants |
Other Pre-specified
Number of Participants With Aneurysm Rupture
Clinically reported rupture events.
Time frame: Two years
Population: Full analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doxycycline | Number of Participants With Aneurysm Rupture | 0 Participants |
| Placebo | Number of Participants With Aneurysm Rupture | 0 Participants |
Other Pre-specified
Number of Participants With Surgical Intervention
Clinically reported aneurysm repair.
Time frame: Two years
Population: Full analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doxycycline | Number of Participants With Surgical Intervention | 13 Participants |
| Placebo | Number of Participants With Surgical Intervention | 9 Participants |