ComplicationPhase 4NCT02744937
Continuing Low Dose Aspirin Before Prostate Biopsy
A Phase 4 study testing Aspirin in people with Complication, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Complication
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Angina in the past 3 months
- Exertional dyspnea on walking or climbing stairs for one floor
- Stroke in the past 6 months
- Coronary catheterization in the past 6 months
- Left main disease or 3-vessel disease
- Prior coronary arterial bypass graft surgery
Show all 10Show fewer
- Use of dual (or more) antiplatelet agents
- Coagulopathy or diseases with bleeding tendency
- Hemorrhoid, anal or rectal diseases
- History of urinary stone or tumor
About this study
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
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.
Read the 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.
- Conditions
- Complication
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
aspirin is continued by its regular dosing
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | continuing LDA Receives: Drug: Aspirin |
| B | No intervention | discontinuing LDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compications
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744937
- Sponsor's protocol ID
- 201601033MINC
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maan Z, Cutting CW, Patel U, Kerry S, Pietrzak P, Perry MJ, Kirby RS. Morbidity of transrectal ultrasonography-guided prostate biopsies in patients after the continued use of low-dose aspirin. BJU Int. 2003 Jun;91(9):798-800. doi: 10.1046/j.1464-410x.2003.04238.x.
PubMed 12780835Berger AP, Gozzi C, Steiner H, Frauscher F, Varkarakis J, Rogatsch H, Bartsch G, Horninger W. Complication rate of transrectal ultrasound guided prostate biopsy: a comparison among 3 protocols with 6, 10 and 15 cores. J Urol. 2004 Apr;171(4):1478-80; discussion 1480-1. doi: 10.1097/01.ju.0000116449.01186.f7.
PubMed 15017202Ihezue CU, Smart J, Dewbury KC, Mehta R, Burgess L. Biopsy of the prostate guided by transrectal ultrasound: relation between warfarin use and incidence of bleeding complications. Clin Radiol. 2005 Apr;60(4):459-63; discussion 457-8. doi: 10.1016/j.crad.2004.10.014.
PubMed 15767103Chiang IN, Chang SJ, Pu YS, Huang KH, Yu HJ, Huang CY. Major complications and associated risk factors of transrectal ultrasound guided prostate needle biopsy: a retrospective study of 1875 cases in taiwan. J Formos Med Assoc. 2007 Nov;106(11):929-34. doi: 10.1016/S0929-6646(08)60063-7.
PubMed 18063514Ehrlich Y, Yossepowitch O, Margel D, Lask D, Livne PM, Baniel J. Early initiation of aspirin after prostate and transurethral bladder surgeries is not associated with increased incidence of postoperative bleeding: a prospective, randomized trial. J Urol. 2007 Aug;178(2):524-8; discussion 528. doi: 10.1016/j.juro.2007.03.134. Epub 2007 Jun 14.
PubMed 17570430Giannarini G, Mogorovich A, Valent F, Morelli G, De Maria M, Manassero F, Barbone F, Selli C. Continuing or discontinuing low-dose aspirin before transrectal prostate biopsy: results of a prospective randomized trial. Urology. 2007 Sep;70(3):501-5. doi: 10.1016/j.urology.2007.04.016. Epub 2007 Aug 3.
PubMed 17688919Ecke TH, Gunia S, Bartel P, Hallmann S, Koch S, Ruttloff J. Complications and risk factors of transrectal ultrasound guided needle biopsies of the prostate evaluated by questionnaire. Urol Oncol. 2008 Sep-Oct;26(5):474-8. doi: 10.1016/j.urolonc.2007.12.003. Epub 2008 Mar 4.
PubMed 18367116Halliwell OT, Yadegafar G, Lane C, Dewbury KC. Transrectal ultrasound-guided biopsy of the prostate: aspirin increases the incidence of minor bleeding complications. Clin Radiol. 2008 May;63(5):557-61. doi: 10.1016/j.crad.2007.09.014. Epub 2008 Jan 11.
PubMed 18374720Carmignani L, Picozzi S, Bozzini G, Negri E, Ricci C, Gaeta M, Pavesi M. Transrectal ultrasound-guided prostate biopsies in patients taking aspirin for cardiovascular disease: A meta-analysis. Transfus Apher Sci. 2011 Dec;45(3):275-80. doi: 10.1016/j.transci.2011.10.008. Epub 2011 Oct 24.
PubMed 22030310Chowdhury R, Abbas A, Idriz S, Hoy A, Rutherford EE, Smart JM. Should warfarin or aspirin be stopped prior to prostate biopsy? An analysis of bleeding complications related to increasing sample number regimes. Clin Radiol. 2012 Dec;67(12):e64-70. doi: 10.1016/j.crad.2012.08.005. Epub 2012 Sep 7.
PubMed 22959852Raheem OA, Casey RG, Galvin DJ, Manecksha RP, Varadaraj H, McDermott T, Grainger R, Lynch TH. Discontinuation of anticoagulant or antiplatelet therapy for transrectal ultrasound-guided prostate biopsies: a single-center experience. Korean J Urol. 2012 Apr;53(4):234-9. doi: 10.4111/kju.2012.53.4.234. Epub 2012 Apr 18.
PubMed 22536465Wang J, Zhang C, Tan G, Chen W, Yang B, Tan D. Risk of bleeding complications after preoperative antiplatelet withdrawal versus continuing antiplatelet drugs during transurethral resection of the prostate and prostate puncture biopsy: a systematic review and meta-analysis. Urol Int. 2012;89(4):433-8. doi: 10.1159/000343733. Epub 2012 Nov 13.
PubMed 23154789Culkin DJ, Exaire EJ, Green D, Soloway MS, Gross AJ, Desai MR, White JR, Lightner DJ. Anticoagulation and antiplatelet therapy in urological practice: ICUD/AUA review paper. J Urol. 2014 Oct;192(4):1026-34. doi: 10.1016/j.juro.2014.04.103. Epub 2014 May 21.
PubMed 24859439
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02744937
- Acronym / sponsor ID
- 201601033MINC
- Conditions
- Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Aspirincontinuing LDA |
| B | No intervention | –discontinuing LDA |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Angina in the past 3 months
- Exertional dyspnea on walking or climbing stairs for one floor
- Stroke in the past 6 months
- Coronary catheterization in the past 6 months
- Left main disease or 3-vessel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirinaspirin is continued by its regular dosing | Drug | A |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Results publication: PubMed 12780835Maan Z, Cutting CW, Patel U, Kerry S, Pietrzak P, Perry MJ, Kirby RS. Morbidity of transrectal ultrasonography-guided prostate biopsies in patients after the continued use of low-dose aspirin. BJU Int. 2003 Jun;91(9):798-800. doi: 10.1046/j.1464-410x.2003.04238.x.
- Results publication: PubMed 15017202Berger AP, Gozzi C, Steiner H, Frauscher F, Varkarakis J, Rogatsch H, Bartsch G, Horninger W. Complication rate of transrectal ultrasound guided prostate biopsy: a comparison among 3 protocols with 6, 10 and 15 cores. J Urol. 2004 Apr;171(4):1478-80; discussion 1480-1. doi: 10.1097/01.ju.0000116449.01186.f7.
- Results publication: PubMed 15767103Ihezue CU, Smart J, Dewbury KC, Mehta R, Burgess L. Biopsy of the prostate guided by transrectal ultrasound: relation between warfarin use and incidence of bleeding complications. Clin Radiol. 2005 Apr;60(4):459-63; discussion 457-8. doi: 10.1016/j.crad.2004.10.014.
- Results publication: PubMed 18063514Chiang IN, Chang SJ, Pu YS, Huang KH, Yu HJ, Huang CY. Major complications and associated risk factors of transrectal ultrasound guided prostate needle biopsy: a retrospective study of 1875 cases in taiwan. J Formos Med Assoc. 2007 Nov;106(11):929-34. doi: 10.1016/S0929-6646(08)60063-7.
- Results publication: PubMed 17570430Ehrlich Y, Yossepowitch O, Margel D, Lask D, Livne PM, Baniel J. Early initiation of aspirin after prostate and transurethral bladder surgeries is not associated with increased incidence of postoperative bleeding: a prospective, randomized trial. J Urol. 2007 Aug;178(2):524-8; discussion 528. doi: 10.1016/j.juro.2007.03.134. Epub 2007 Jun 14.
- Results publication: PubMed 17688919Giannarini G, Mogorovich A, Valent F, Morelli G, De Maria M, Manassero F, Barbone F, Selli C. Continuing or discontinuing low-dose aspirin before transrectal prostate biopsy: results of a prospective randomized trial. Urology. 2007 Sep;70(3):501-5. doi: 10.1016/j.urology.2007.04.016. Epub 2007 Aug 3.
- Results publication: PubMed 18367116Ecke TH, Gunia S, Bartel P, Hallmann S, Koch S, Ruttloff J. Complications and risk factors of transrectal ultrasound guided needle biopsies of the prostate evaluated by questionnaire. Urol Oncol. 2008 Sep-Oct;26(5):474-8. doi: 10.1016/j.urolonc.2007.12.003. Epub 2008 Mar 4.
- Results publication: PubMed 18374720Halliwell OT, Yadegafar G, Lane C, Dewbury KC. Transrectal ultrasound-guided biopsy of the prostate: aspirin increases the incidence of minor bleeding complications. Clin Radiol. 2008 May;63(5):557-61. doi: 10.1016/j.crad.2007.09.014. Epub 2008 Jan 11.
- Results publication: PubMed 22030310Carmignani L, Picozzi S, Bozzini G, Negri E, Ricci C, Gaeta M, Pavesi M. Transrectal ultrasound-guided prostate biopsies in patients taking aspirin for cardiovascular disease: A meta-analysis. Transfus Apher Sci. 2011 Dec;45(3):275-80. doi: 10.1016/j.transci.2011.10.008. Epub 2011 Oct 24.
- Results publication: PubMed 22959852Chowdhury R, Abbas A, Idriz S, Hoy A, Rutherford EE, Smart JM. Should warfarin or aspirin be stopped prior to prostate biopsy? An analysis of bleeding complications related to increasing sample number regimes. Clin Radiol. 2012 Dec;67(12):e64-70. doi: 10.1016/j.crad.2012.08.005. Epub 2012 Sep 7.
- Results publication: PubMed 22536465Raheem OA, Casey RG, Galvin DJ, Manecksha RP, Varadaraj H, McDermott T, Grainger R, Lynch TH. Discontinuation of anticoagulant or antiplatelet therapy for transrectal ultrasound-guided prostate biopsies: a single-center experience. Korean J Urol. 2012 Apr;53(4):234-9. doi: 10.4111/kju.2012.53.4.234. Epub 2012 Apr 18.
- Results publication: PubMed 23154789Wang J, Zhang C, Tan G, Chen W, Yang B, Tan D. Risk of bleeding complications after preoperative antiplatelet withdrawal versus continuing antiplatelet drugs during transurethral resection of the prostate and prostate puncture biopsy: a systematic review and meta-analysis. Urol Int. 2012;89(4):433-8. doi: 10.1159/000343733. Epub 2012 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Complication
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Complication, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compications (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744937, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.