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The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin

NCT01549418 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2012-03-09

No results posted yet for this study

Summary

The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (\>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.

Conditions

  • Gastrointestinal Hemorrhage

Interventions

DRUG

Aspirin (ASA)

Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy

DRUG

Placebo

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    collaborator OTHER

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Regula Jaroslaw, MD PhD · The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

  • Kaminski F Michal, MD · The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

  • Pisera Malgorzata, MSc · The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Entities

Drugs

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 NCT01549418 on ClinicalTrials.gov