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

Gastrointestinal Hemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01549418
• Other study ID #: ASAPOL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: March 8, 2012
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: March 2012
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Kaminski F Michal, MD
• Phone: 48 22 546 30 56
• Email: mfkaminski[@]coi.waw.pl
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 760
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Drug:
• Aspirin (ASA)
Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Medical Centre of Postgraduate Education, Poland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;	within 30 days after polypectomy	Yes
Secondary	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	in time from randomisation to 30 days after polipectomy	Yes
Secondary	Proportion of clinically significant delayed bleeding in both groups		within 30 days after polipectomy	Yes