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

March 8, 2012 updated by: Jaroslaw Regula, Maria Sklodowska-Curie National Research Institute of Oncology

The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1). The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo and prepared for the study (Visit 2). Patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (Visit 3). 30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will be monitored by looking at the end points.

Study Type

Interventional

Enrollment (Anticipated)

760

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 40 years or older
  2. Daily aspirin for primary or secondary prophylaxis
  3. Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
  4. Signed written informed consent
  5. Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period

Exclusion Criteria:

  1. Lifelong anticoagulant therapy with warfarin, acenocumarol
  2. Concurrent antiplatelet treatment with clopidogrel or ticlopidin
  3. Coagulation disorders INR > 1,5, APTT 2xnorm
  4. Known hemorrhagic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Aspirin
Patients with at least one large polyps taking aspirin in dose 75 mg daily for 21 days (7 days before and 14 days after polypectomy)
Drug: Aspirin (ASA)
Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
Other Names:
  • Not yet named
PLACEBO_COMPARATOR: Placebo
Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant bleeding after colorectal polypectomy
Time Frame: within 30 days after polypectomy
Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site [immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions;
within 30 days after polypectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo
Time Frame: in time from randomisation to 30 days after polipectomy
Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke
in time from randomisation to 30 days after polipectomy
Proportion of clinically significant delayed bleeding in both groups
Time Frame: within 30 days after polipectomy
within 30 days after polipectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Centre of Postgraduate Medical Education

Investigators

  • Study Director: Regula Jaroslaw, MD PhD, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
  • Study Chair: Kaminski F Michal, MD, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
  • Principal Investigator: Pisera Malgorzata, MSc, The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2015

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAPOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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