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Trial Title:
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
NCT ID:
NCT01549418
Condition:
Gastrointestinal Hemorrhage
Conditions: Official terms:
Gastrointestinal Hemorrhage
Hemorrhage
Aspirin
Conditions: 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
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Aspirin (ASA)
Description:
Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after
polypectomy
Arm group label:
Aspirin
Other name:
Not yet named
Intervention type:
Drug
Intervention name:
Placebo
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2012
Completion date:
September 2015
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Centre of Postgraduate Medical Education
Agency class:
Other
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01549418
