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Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial

NCT ID: NCT01756833

Last Updated: 2021-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-07-23

Brief Summary

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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

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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.

Conditions

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Aneurysm

Keywords

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abdominal aortic aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Doxycycline

100 mg capsules, twice a day, for a period of two years.

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

100 mg po bid

Placebo

100 mg capsules, twice a day, for a period of two years.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule identical to the doxycycline capsule

Interventions

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Doxycycline

100 mg po bid

Intervention Type DRUG

Placebo

capsule identical to the doxycycline capsule

Intervention Type DRUG

Other Intervention Names

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doxycycline hyclate Vibramycin Oracea Adoxa Atridox and others capsule containing inert filler

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Michael Terrin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Terrin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Bernard T Baxter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Jonathan Matsumura, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Medical Center

John Curci, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Carondelet Heart & Vascular Institute

Tucson, Arizona, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Miami Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

University of South Florida Health Center

Tampa, Florida, United States

Site Status

Northwestern University Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconness Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

McLaren Northern Michigan

Petoskey, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Omaha VAMC

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Portland VAMC

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status

Utah VAMC

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27018941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32986071 (View on PubMed)

Lachin JM. Nonparametric Statistical Analysis. JAMA. 2020 May 26;323(20):2080-2081. doi: 10.1001/jama.2020.5874. No abstract available.

Reference Type BACKGROUND
PMID: 32453350 (View on PubMed)

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.

Reference Type RESULT
PMID: 32453369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34655683 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33957227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33595625 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AG037120

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00051170

Identifier Type: -

Identifier Source: org_study_id