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

Primary Purpose

Gastrointestinal Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin (ASA)
Placebo
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Hemorrhage focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Aspirin

    Placebo

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    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;

    Secondary Outcome Measures

    Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo
    Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke
    Proportion of clinically significant delayed bleeding in both groups

    Full Information

    First Posted
    March 6, 2012
    Last Updated
    March 8, 2012
    Sponsor
    Maria Sklodowska-Curie National Research Institute of Oncology
    Collaborators
    Centre of Postgraduate Medical Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01549418
    Brief Title
    The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
    Acronym
    ASAPOL
    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

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maria Sklodowska-Curie National Research Institute of Oncology
    Collaborators
    Centre of Postgraduate Medical Education

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    760 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aspirin
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin (ASA)
    Other Intervention Name(s)
    Not yet named
    Intervention Description
    Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Clinically significant bleeding after colorectal polypectomy
    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;
    Time Frame
    within 30 days after polypectomy
    Secondary Outcome Measure Information:
    Title
    Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo
    Description
    Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke
    Time Frame
    in time from randomisation to 30 days after polipectomy
    Title
    Proportion of clinically significant delayed bleeding in both groups
    Time Frame
    within 30 days after polipectomy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Lifelong anticoagulant therapy with warfarin, acenocumarol Concurrent antiplatelet treatment with clopidogrel or ticlopidin Coagulation disorders INR > 1,5, APTT 2xnorm Known hemorrhagic disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kaminski F Michal, MD
    Phone
    48 22 546 30 56
    Email
    mfkaminski@coi.waw.pl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pisera Malgorzata, MSc
    Phone
    48 22 546 30 58
    Email
    mpisera@coi.waw.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Regula Jaroslaw, MD PhD
    Organizational Affiliation
    The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kaminski F Michal, MD
    Organizational Affiliation
    The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Pisera Malgorzata, MSc
    Organizational Affiliation
    The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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