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Continuing Low Dose Aspirin Before Prostate Biopsy

2016年4月18日 更新者:National Taiwan University Hospital

To Investigate Post-procedure Hemorrhage and Cardiovascular Events in Taiwanese Patients Who Continue or Discontinue Low-Dose Aspirin Before Transrectal Prostate Biopsy: a Prospective Randomized Trial

Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of bleeding complications.

Eligibility: Men over 40-year-old with an elevated serum prostate-specific antigen level and/or abnormal digital rectal examination findings are candidates for PB.

Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of bleeding complications Statistical analysis and sample size estimation: Fisher's exact test or chi-square test will be used to explore the differences between two groups for categorical variables, and Student t-test will be used for continuous variables. Under the assumption of a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60 subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit number is 150 in total.

研究概览

地位

未知

条件

干预/治疗

详细说明

Transrectal ultrasound (TRUS)-guided prostate biopsy (PB) is currently the standard for diagnosing prostate cancer and is one of the most commonly performed urologic procedures.

The complications that can occur after this procedure have been extensively described previously. Bleeding complications, namely hematuria, rectal bleeding, and hematospermia, are the most frequent, with a reported incidence of 20% to 70%, but they are almost exclusively self-limiting and of mild to moderate severity.

There is an increasing number of patients who require PB and antiplatelet medication simultaneously. This is because more middle-age and elderly patients are receiving long-term antithrombotic therapy mainly for prevention of cardiovascular events, and these patients form the majority of those at risk of prostate cancer. As with other surgical interventions, aspirin is typically discontinued 7 to 10 days before PB. However, discontinuing aspirin might increase the risk of cardiovascular events, while continuing aspirin before PB might not necessarily increase severe bleeding complications. Several studies have found no increase in bleeding complications in patients continuing low-dose aspirin. However, most of the studies were retrospective, and only one was randomized. Moreover, there has been no prospective randomized trial in East Asian patients, who have a lower risk of thrombosis and increased risk of bleeding during antithrombotic treatment for acute coronary syndrome than do white patients.

The aim of the present randomized study was to determine whether TRUS-guided PB performed in patients continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of bleeding complications.

研究类型

介入性

注册 (预期的)

150

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

The inclusion criteria are use of LDA (100 mg once daily) for primary prevention of cardiovascular disease and not at a high risk of cardiovascular event. The definition of high risk includes #1-7 of the following exclusion criteria or unsuitable conditions by clinical judgement.

Exclusion Criteria:

  1. Angina in the past 3 months
  2. Exertional dyspnea on walking or climbing stairs for one floor
  3. Stroke in the past 6 months
  4. Coronary catheterization in the past 6 months
  5. Left main disease or 3-vessel disease
  6. Prior coronary arterial bypass graft surgery
  7. Use of dual (or more) antiplatelet agents
  8. Coagulopathy or diseases with bleeding tendency
  9. Hemorrhoid, anal or rectal diseases
  10. History of urinary stone or tumor

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:A
continuing LDA
aspirin is continued by its regular dosing
无干预:B
discontinuing LDA

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Compications
大体时间:3 weeks
To determine whether the incidence, duration, and severity of bleeding complications after transrectal prostate biopsy (PB) in patients not discontinuing low-dose aspirin (LDA) are greater than in those discontinuing it.
3 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年4月1日

初级完成 (预期的)

2019年3月1日

研究注册日期

首次提交

2016年4月18日

首先提交符合 QC 标准的

2016年4月18日

首次发布 (估计)

2016年4月20日

研究记录更新

最后更新发布 (估计)

2016年4月20日

上次提交的符合 QC 标准的更新

2016年4月18日

最后验证

2016年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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