Continuing Low Dose Aspirin Before Prostate Biopsy

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Aspirin

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