Clinical trial NCT01549418: The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
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
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2012-03-09
Enrollment: 760
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Clinically significant bleeding after colorectal polypectomy
timeFrame: within 30 days after polypectomy
Secondary outcomes:
measure: Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo
timeFrame: in time from randomisation to 30 days after polipectomy
measure: Proportion of clinically significant delayed bleeding in both groups
timeFrame: within 30 days after polipectomy
Other outcomes:
Locations:
Study officials:
affiliation: The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
name: Regula Jaroslaw, MD PhD
role: STUDY_DIRECTOR
affiliation: The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
name: Kaminski F Michal, MD
role: STUDY_CHAIR
affiliation: The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
name: Pisera Malgorzata, MSc
role: PRINCIPAL_INVESTIGATOR
References: