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Continuing Low Dose Aspirin Before Prostate Biopsy

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ClinicalTrials.gov Identifier: NCT02744937
Recruitment Status : Unknown
Verified April 2016 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Complication Drug: Aspirin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: A
continuing LDA
Drug: Aspirin
aspirin is continued by its regular dosing

No Intervention: B
discontinuing LDA



Primary Outcome Measures :
  1. Compications [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:

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Responsible Party: National Taiwan University Hospital, V.S.
ClinicalTrials.gov Identifier: NCT02744937     History of Changes
Other Study ID Numbers: 201601033MINC
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics