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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Unknown; Phase 4

Conditions: Gastrointestinal Hemorrhage

Treatments: Drug: Aspirin (ASA); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01549418

ASAPOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 760 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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760 participants in 2 patient groups, including a placebo group

Aspirin

Active Comparator group

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)

Treatment:

Drug: Aspirin (ASA)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo