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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Aspirin (ASA)

Intervention Type DRUG

Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Aspirin (ASA)

Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Not yet named

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No