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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Sponsor:
Collaborator:
Medical Centre of Postgraduate Education, Poland
Information provided by (Responsible Party):
Jaroslaw Regula, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01549418
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012

March 6, 2012
March 8, 2012
September 2012
September 2015   (final data collection date for primary outcome measure)
Clinically significant bleeding after colorectal polypectomy [ Time Frame: within 30 days after polypectomy ] [ Designated as safety issue: Yes ]
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;
Same as current
Complete list of historical versions of study NCT01549418 on ClinicalTrials.gov Archive Site
  • Proportion of composite cardiovascular events, ending unplanned hospitalization in both groups aspirin and placebo [ Time Frame: in time from randomisation to 30 days after polipectomy ] [ Designated as safety issue: Yes ]
    Composite cardiovascular events - acute coronary syndrome, transient ischemic attack (TIA)or stroke
  • Proportion of clinically significant delayed bleeding in both groups [ Time Frame: within 30 days after polipectomy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Gastrointestinal Hemorrhage
  • Drug: Aspirin (ASA)
    Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
    Other Name: Not yet named
  • Drug: Placebo
  • Active Comparator: Aspirin
    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)
    Intervention: Drug: Aspirin (ASA)
  • Placebo Comparator: Placebo
    Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
760
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Kaminski F Michal, MD 48 22 546 30 56 mfkaminski@coi.waw.pl
Contact: Pisera Malgorzata, MSc 48 22 546 30 58 mpisera@coi.waw.pl
Not Provided
 
NCT01549418
ASAPOL
Yes
Jaroslaw Regula, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Medical Centre of Postgraduate Education, Poland
Study Director: Regula Jaroslaw, MD PhD The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Study Chair: Kaminski F Michal, MD The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Principal Investigator: Pisera Malgorzata, MSc The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP