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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


Phase 4
40 Years
N/A
Not Enrolling
Both
Gastrointestinal Hemorrhage

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Clinically significant bleeding after colorectal polypectomy

Outcome Description:

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;

Outcome Time Frame:

within 30 days after polypectomy

Safety Issue:

Yes

Principal Investigator

Regula Jaroslaw, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

ASAPOL

NCT ID:

NCT01549418

Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Gastrointestinal Hemorrhage
  • 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
  • Gastrointestinal Hemorrhage
  • Hemorrhage
  • Colonic Polyps

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