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

NCT01549418 | Unknown Phase 4 DMC

• 1 other identifier: ASAPOL
• Study Type: interventional
• Target: 760
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gastrointestinal bleeding; Lower gastrointestinal bleeding (LGIB); Polypectomy; Large colorectal polyps; ASA; Aspirin; Acetylsalicylic acid; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Outcome Measures

Primary Outcomes (1)

• Clinically significant bleeding after colorectal 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 Outcomes (2)

• Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo

  in time from randomisation to 30 days after polipectomy

• Proportion of clinically significant delayed bleeding in both groups

  within 30 days after polipectomy

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)

Drug: Placebo

Interventions

Aspirin (ASA) DRUG

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

Also known as: Not yet named

Aspirin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Regula Jaroslaw, MD PhD

  The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

  STUDY DIRECTOR

• Kaminski F Michal, MD

  The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

  STUDY CHAIR

• Pisera Malgorzata, MSc

  The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaminski F Michal, MD

CONTACT

48 22 546 30 56; mfkaminski@coi.waw.pl

Pisera Malgorzata, MSc

CONTACT

48 22 546 30 58; mpisera@coi.waw.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Gastroenterology, MD, PhD

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 9, 2012

Record last verified: 2012-03