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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01549418
Other study ID # ASAPOL
Secondary ID
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


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
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