Aortic AneurysmNCT00126204
Adjunctive Treatment With Doxycycline to Enhance the Durability of Endovascular Aortic Aneurysm Repair
A study testing Doxycycline in people with Aortic Aneurysm, run by The Foundation for Barnes-Jewish Hospital at 1 site in United States.
Trial summary
The durability of endovascular aneurysm repair (EVAR) has been limited by development of endoleaks which may be secondary to progressive aortic degeneration by matrix metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in aneurysms. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Doxycycline
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of an abdominal aortic aneurysm (AAA) with a maximum diameter of > or = 4.5 cm
- Planned aneurysm exclusion with endoluminal stent graft (any brand)
Who cannot join
- Known malignancy not to include prostate cancer or any history of cancer that has not had a recurrence in the last 5 years.
- Hypersensitivity to doxycycline or any of its components
- Pregnancy
- Ruptured AAA
- Extension of covered portion of the graft above the renal arteries
- Previous endoluminal aneurysm repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine / Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Adjunctive Treatment With Doxycycline in Endovascular Aneurysm Repair
The durability of endovascular aneurysm repair (EVAR) has been limited by development of endoleaks which may be secondary to progressive aortic degeneration by matrix metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum markers of aneurysmal degeneration.
Read the detailed description
Patients will be consented and enrolled at the time of their clinic visit or admission to the hospital for a planned EVAR, in accordance with institutional review board guidelines. Demographic, risk factor and medication regimen data will be obtained from the patient's clinical chart. Patients will be randomized to doxycycline therapy (100 mg taken twice daily) or a placebo. The patients will receive their first dose of study medication on the day following surgery, and continue the study therapy for 6 months.
Plasma and serum will be obtained at the time of enrollment (baseline), and at each post-operative follow-up visit during the study as outlined above. Aliquots will be stored at -80ºC until assayed. Measurements of the circulating markers will be performed by commercially available assays for plasma MMP-9 (R\&D Systems, Minneapolis, MN), serum IL-6 (R\&D Systems) , IL-8 (R\&D Systems), IFN-gamma (R\&D Systems), and CRP (Bio-Check, Burlingame, CA) Data will be collected from the pre-operative and all post-operative CT scans regarding maximal aneurysm diameter and transverse neck diameter at 5 mm, 10 mm and 15 mm below the takeoff of the lowest renal artery. All documented endoleaks and their clinical type will be recorded, as will any re-intervention related to the graft or aneurysm.
The primary end-points of the study related to aneurysm measurements will be an increase or decrease in any of the diameter measurements of the aorta by 2 mm or more on 2 consecutive CT scans or a change of 5 mm or more on any single scan. Of the circulating markers, an additional primary endpoint will be a 50% reduction in baseline MMP-9 after endografting. Secondary endpoints will be significant reductions over baseline in circulating IL-6, IL-8, IFN-γ, and CRP. An a priori power analysis indicates that at 6 months, reductions in circulating levels of these markers by 50% can be detected with a β-error of less than 0.1 and α-error of less than 0.05.
- Conditions
- Aortic Aneurysm
- Being tested
- Doxycycline
- Keywords
- endoleak, doxycycline, matrix metalloproteinase, inflammation, endograft, circulating markers
- Medical subject headings
- Aortic Aneurysm, Endoleak, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic measurements by > 2 mm on 2 consecutive scans
Change in aortic measurement by > 5 mm on a single scan
50% reduction in baseline plasma MMP-9 at 6 months
Secondary outcomes (4)
Significant reductions at 6 months in serum interleukin-6 (IL-6)
Significant reductions at 6 months in serum IL-8
Significant reductions at 6 months in serum interferon-gamma
Significant reductions at 6 months in serum C-reactive protein
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startMar 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- The Foundation for Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Investigators
- John A Curci, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126204
- Sponsor's protocol ID
- 00012-0904-02
- Status last verified
- Sep 2006
- First submitted
- 2 Aug 2005
- Last updated
- 4 Mar 2010
- Results posted
- No
Publications
Hackmann AE, Rubin BG, Sanchez LA, Geraghty PA, Thompson RW, Curci JA. A randomized, placebo-controlled trial of doxycycline after endoluminal aneurysm repair. J Vasc Surg. 2008 Sep;48(3):519-26; discussion 526. doi: 10.1016/j.jvs.2008.03.064. Epub 2008 Jul 15.
PubMed 18632241
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Treatment With Doxycycline in Endovascular Aneurysm Repair
- ClinicalTrials.gov ID
- NCT00126204
- Acronym / sponsor ID
- 00012-0904-02
- Conditions
- Aortic Aneurysm
- Keywords
- endoleak, doxycycline, matrix metalloproteinase, inflammation, endograft, circulating markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- The Foundation for Barnes-Jewish HospitalUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jul 2006
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The durability of endovascular aneurysm repair (EVAR) has been limited by development of endoleaks which may be secondary to progressive aortic degeneration by matrix metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum markers of aneurysmal degeneration.
Detailed description
Patients will be consented and enrolled at the time of their clinic visit or admission to the hospital for a planned EVAR, in accordance with institutional review board guidelines. Demographic, risk factor and medication regimen data will be obtained from the patient's clinical chart. Patients will be randomized to doxycycline therapy (100 mg taken twice daily) or a placebo. The patients will receive their first dose of study medication on the day following surgery, and continue the study therapy for 6 months.
Plasma and serum will be obtained at the time of enrollment (baseline), and at each post-operative follow-up visit during the study as outlined above. Aliquots will be stored at -80ºC until assayed. Measurements of the circulating markers will be performed by commercially available assays for plasma MMP-9 (R\&D Systems, Minneapolis, MN), serum IL-6 (R\&D Systems) , IL-8 (R\&D Systems), IFN-gamma (R\&D Systems), and CRP (Bio-Check, Burlingame, CA) Data will be collected from the pre-operative and all post-operative CT scans regarding maximal aneurysm diameter and transverse neck diameter at 5 mm, 10 mm and 15 mm below the takeoff of the lowest renal artery. All documented endoleaks and their clinical type will be recorded, as will any re-intervention related to the graft or aneurysm.
The primary end-points of the study related to aneurysm measurements will be an increase or decrease in any of the diameter measurements of the aorta by 2 mm or more on 2 consecutive CT scans or a change of 5 mm or more on any single scan. Of the circulating markers, an additional primary endpoint will be a 50% reduction in baseline MMP-9 after endografting. Secondary endpoints will be significant reductions over baseline in circulating IL-6, IL-8, IFN-γ, and CRP. An a priori power analysis indicates that at 6 months, reductions in circulating levels of these markers by 50% can be detected with a β-error of less than 0.1 and α-error of less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of an abdominal aortic aneurysm (AAA) with a maximum diameter of > or = 4.5 cm
- Planned aneurysm exclusion with endoluminal stent graft (any brand)
Key exclusion criteria (6 listed)
- Known malignancy not to include prostate cancer or any history of cancer that has not had a recurrence in the last 5 years.
- Hypersensitivity to doxycycline or any of its components
- Pregnancy
- Ruptured AAA
- Extension of covered portion of the graft above the renal arteries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline | Drug | – |
Primary outcome
Change in aortic measurements by > 2 mm on 2 consecutive scans
Change in aortic measurement by > 5 mm on a single scan
50% reduction in baseline plasma MMP-9 at 6 months
4 secondary outcomes
Significant reductions at 6 months in serum interleukin-6 (IL-6)
Significant reductions at 6 months in serum IL-8
Significant reductions at 6 months in serum interferon-gamma
Significant reductions at 6 months in serum C-reactive protein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2010.
- Results publication: PubMed 18632241Hackmann AE, Rubin BG, Sanchez LA, Geraghty PA, Thompson RW, Curci JA. A randomized, placebo-controlled trial of doxycycline after endoluminal aneurysm repair. J Vasc Surg. 2008 Sep;48(3):519-26; discussion 526. doi: 10.1016/j.jvs.2008.03.064. Epub 2008 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Curci, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline in people with Aortic Aneurysm, run by The Foundation for Barnes-Jewish Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aortic measurements by > 2 mm on 2 consecutive scans. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2010.