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.
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.
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DOI：
10.1016/j.cct.2016.03.008
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发表时间：
2016-05
影响因子：
2.2
通讯作者：
N-TA(3)CT Investigators
中科院分区：
文献类型：
--
作者：
Baxter BT;Matsumura J;Curci J;McBride R;Blackwelder WC;Liu X;Larson L;Terrin ML;N-TA(3)CT Investigators
腹主动脉瘤无创治疗临床试验（N-TA 3CT）是一项IIb期随机、安慰剂对照临床试验，旨在测试多西环素（100 mg bid）对最大横向、正交直径的小腹主动脉瘤（AAA）生长的抑制作用。我们将入组258例年龄≥ 55岁的AAA患者，男性：3.5-5.0 cm，女性：3.5-4.5 cm，经CT扫描中心确认。主要结局是从基线到24个月随访的最大横向、正交直径的增长。次要分析讨论了多西环素对临床事件、动脉瘤体积和生物标志物的影响。主要分析将根据死亡和破裂的意向治疗解释原则进行，在协方差分析中使用正态评分。在报告数据文件时，已对200例受试者进行了随机化。我们于2013年年中开始入组，并将于2016年年中完成入组。参与者平均年龄= 70.9岁（SD = 7.6岁），男性最大横径= 4.3 cm（SD = 0.4），女性4.0 cm（SD = 0.3）。N-TA 3CT是一项关键实验，用于确定多西环素是否减少小AAA的生长以及先前在实验室实验和观察性人体研究中观察到的与AAA生长相关的全身炎症标志物。我们的患者人群基线测量结果与设计假设一致，支持我们的预期，即当生长减少至少40%时，90%或更高的把握度拒绝零假设，支持备择假设。注册：clinicaltrials.gov #NCT01756833。
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). 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. 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). 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.