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
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Hemorrhage
Drug: Aspirin (ASA)
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • 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;


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 760
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Placebo Comparator: Placebo
Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
Drug: Placebo

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549418

Contacts
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

Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Medical Centre of Postgraduate Education, Poland
Investigators
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
  More Information

No publications provided

Responsible Party: Jaroslaw Regula, Professor in Gastroenterology, MD, PhD, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01549418     History of Changes
Other Study ID Numbers: ASAPOL
Study First Received: March 6, 2012
Last Updated: March 8, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
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

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014