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Continuing Low Dose Aspirin Before Prostate Biopsy

NCT02744937 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-04-20

No results posted yet for this study

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.

Conditions

  • Complication

Interventions

DRUG

Aspirin

aspirin is continued by its regular dosing

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744937 on ClinicalTrials.gov