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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549418

Acronym

ASAPOL

Enrollment

760

Registered

2012-03-09

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

DRUGAspirin (ASA)

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinically significant bleeding after colorectal polypectomy	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;

Secondary

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

Contacts

Primary ContactKaminski F Michal, MD

mfkaminski@coi.waw.pl48 22 546 30 56

Backup ContactPisera Malgorzata, MSc

mpisera@coi.waw.pl48 22 546 30 58

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026