Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT)

Design of a Phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm

for the N-TA3CT Investigators

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives: The Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) is a Phase IIb randomized, placebo-controlled clinical trial, testing doxycycline (100 mg bid) for inhibition of growth in the greatest transverse, orthogonal diameter of small abdominal aortic aneurysms (AAA). Methods: We will enroll 258 patients, ≥. 55 years of age who have AAA, men: 3.5-5.0 cm and women: 3.5-4.5 cm on CT scans confirmed centrally. The primary outcome is growth in maximal transverse, orthogonal diameter from baseline to 24-month follow-up. Secondary analyses address doxycycline effects on clinical events, aneurysm volume, and biomarkers. Primary analysis will be performed according to the principle of intention-to-treat accounting for death and ruptures by use of normal scores in analysis of covariance. At the time of the data file reported, 200 subjects have been randomized. We started enrollment in mid-2013 and will complete enrollment by mid-2016. Results: Participant average age = 70.9 years, (SD = 7.6 years) and maximum transverse diameter = 4.3 cm for men (SD = 0.4) and 4.0 cm for women (SD = 0.3). Conclusion: N-TA3CT is a critical experiment to determine whether doxycycline reduces growth of small AAA and systemic markers of inflammation previously seen in bench experiments and observational human studies to be associated with AAA growth. Our patient population baseline measurements agree with the design assumptions supporting our expectation of 90% power or greater to reject a null hypothesis in favor of an alternative hypothesis when growth is reduced by at least 40%. Registration: clinicaltrials.gov #NCT01756833.

Original languageEnglish (US)
Pages (from-to)91-98
Number of pages8
JournalContemporary Clinical Trials
Volume48
DOIs
StatePublished - May 1 2016

Fingerprint

Doxycycline
Abdominal Aortic Aneurysm
Randomized Controlled Trials
Placebos
Clinical Trials
Growth
Therapeutics
Information Storage and Retrieval
Observational Studies
Aneurysm
Rupture
Biomarkers
Inflammation
Population

Keywords

  • Abdominal
  • Aneurysm
  • Aortic
  • Clinical trial
  • Doxycycline

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{66ec648421ea4766b21787ec0be06cee,
title = "Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT): Design of a Phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm",
abstract = "Objectives: The Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) is a Phase IIb randomized, placebo-controlled clinical trial, testing doxycycline (100 mg bid) for inhibition of growth in the greatest transverse, orthogonal diameter of small abdominal aortic aneurysms (AAA). Methods: We will enroll 258 patients, ≥. 55 years of age who have AAA, men: 3.5-5.0 cm and women: 3.5-4.5 cm on CT scans confirmed centrally. The primary outcome is growth in maximal transverse, orthogonal diameter from baseline to 24-month follow-up. Secondary analyses address doxycycline effects on clinical events, aneurysm volume, and biomarkers. Primary analysis will be performed according to the principle of intention-to-treat accounting for death and ruptures by use of normal scores in analysis of covariance. At the time of the data file reported, 200 subjects have been randomized. We started enrollment in mid-2013 and will complete enrollment by mid-2016. Results: Participant average age = 70.9 years, (SD = 7.6 years) and maximum transverse diameter = 4.3 cm for men (SD = 0.4) and 4.0 cm for women (SD = 0.3). Conclusion: N-TA3CT is a critical experiment to determine whether doxycycline reduces growth of small AAA and systemic markers of inflammation previously seen in bench experiments and observational human studies to be associated with AAA growth. Our patient population baseline measurements agree with the design assumptions supporting our expectation of 90{\%} power or greater to reject a null hypothesis in favor of an alternative hypothesis when growth is reduced by at least 40{\%}. Registration: clinicaltrials.gov #NCT01756833.",
keywords = "Abdominal, Aneurysm, Aortic, Clinical trial, Doxycycline",
author = "{for the N-TA3CT Investigators} and Baxter, {Bernard Timothy} and Jon Matsumura and John Curci and Ruth McBride and Blackwelder, {William C.} and Xinggang Liu and Larson, {Lu Ann} and Terrin, {Michael L.}",
year = "2016",
month = "5",
day = "1",
doi = "10.1016/j.cct.2016.03.008",
language = "English (US)",
volume = "48",
pages = "91--98",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",

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TY - JOUR

T1 - Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT)

T2 - Design of a Phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm

AU - for the N-TA3CT Investigators

AU - Baxter, Bernard Timothy

AU - Matsumura, Jon

AU - Curci, John

AU - McBride, Ruth

AU - Blackwelder, William C.

AU - Liu, Xinggang

AU - Larson, Lu Ann

AU - Terrin, Michael L.

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Objectives: The Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) is a Phase IIb randomized, placebo-controlled clinical trial, testing doxycycline (100 mg bid) for inhibition of growth in the greatest transverse, orthogonal diameter of small abdominal aortic aneurysms (AAA). Methods: We will enroll 258 patients, ≥. 55 years of age who have AAA, men: 3.5-5.0 cm and women: 3.5-4.5 cm on CT scans confirmed centrally. The primary outcome is growth in maximal transverse, orthogonal diameter from baseline to 24-month follow-up. Secondary analyses address doxycycline effects on clinical events, aneurysm volume, and biomarkers. Primary analysis will be performed according to the principle of intention-to-treat accounting for death and ruptures by use of normal scores in analysis of covariance. At the time of the data file reported, 200 subjects have been randomized. We started enrollment in mid-2013 and will complete enrollment by mid-2016. Results: Participant average age = 70.9 years, (SD = 7.6 years) and maximum transverse diameter = 4.3 cm for men (SD = 0.4) and 4.0 cm for women (SD = 0.3). Conclusion: N-TA3CT is a critical experiment to determine whether doxycycline reduces growth of small AAA and systemic markers of inflammation previously seen in bench experiments and observational human studies to be associated with AAA growth. Our patient population baseline measurements agree with the design assumptions supporting our expectation of 90% power or greater to reject a null hypothesis in favor of an alternative hypothesis when growth is reduced by at least 40%. Registration: clinicaltrials.gov #NCT01756833.

AB - Objectives: The Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) is a Phase IIb randomized, placebo-controlled clinical trial, testing doxycycline (100 mg bid) for inhibition of growth in the greatest transverse, orthogonal diameter of small abdominal aortic aneurysms (AAA). Methods: We will enroll 258 patients, ≥. 55 years of age who have AAA, men: 3.5-5.0 cm and women: 3.5-4.5 cm on CT scans confirmed centrally. The primary outcome is growth in maximal transverse, orthogonal diameter from baseline to 24-month follow-up. Secondary analyses address doxycycline effects on clinical events, aneurysm volume, and biomarkers. Primary analysis will be performed according to the principle of intention-to-treat accounting for death and ruptures by use of normal scores in analysis of covariance. At the time of the data file reported, 200 subjects have been randomized. We started enrollment in mid-2013 and will complete enrollment by mid-2016. Results: Participant average age = 70.9 years, (SD = 7.6 years) and maximum transverse diameter = 4.3 cm for men (SD = 0.4) and 4.0 cm for women (SD = 0.3). Conclusion: N-TA3CT is a critical experiment to determine whether doxycycline reduces growth of small AAA and systemic markers of inflammation previously seen in bench experiments and observational human studies to be associated with AAA growth. Our patient population baseline measurements agree with the design assumptions supporting our expectation of 90% power or greater to reject a null hypothesis in favor of an alternative hypothesis when growth is reduced by at least 40%. Registration: clinicaltrials.gov #NCT01756833.

KW - Abdominal

KW - Aneurysm

KW - Aortic

KW - Clinical trial

KW - Doxycycline

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JF - Contemporary Clinical Trials

SN - 1551-7144

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