Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT07185295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy
Sponsor:
Outcomes'10
Organization:
Study Overview
Official Title:
Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy, a Randomized Multicenter Investigator-initiated Non-inferiority Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLYPHEM
Brief Summary:
This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum.
It includes patients who regularly take blood thinners and need an elective colonoscopy.
The main goal is to see how often patients have serious bleeding after the polyp removal within 30 days.
The study is being done in several hospitals, and doctors evaluating the results do not know which treatment patients receive.
It includes patients who regularly take blood thinners and need an elective colonoscopy.
The main goal is to see how often patients have serious bleeding after the polyp removal within 30 days.
The study is being done in several hospitals, and doctors evaluating the results do not know which treatment patients receive.
Detailed Description:
This multicenter, phase IV, assessor-blinded, non-inferiority clinical trial evaluates the safety of maintaining oral anticoagulant therapy during colorectal polypectomy. The study population includes patients receiving chronic oral anticoagulation treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) who are scheduled for elective colonoscopy for any indication.
The primary objective is to assess the incidence of clinically significant post-polypectomy bleeding within 30 days after the procedure. The trial tests the hypothesis that continuing anticoagulant therapy during polypectomy is non-inferior to interrupting it, with a non-inferiority margin set at 10%.
A total of 481 patients will be enrolled, with 241 patients per group. The intervention consists of maintaining ongoing anticoagulant treatment without modification before the procedure. This trial is classified as a low-intervention study according to regulatory guidelines and aims to provide evidence to optimize the management of anticoagulated patients undergoing colorectal polypectomy.
The primary objective is to assess the incidence of clinically significant post-polypectomy bleeding within 30 days after the procedure. The trial tests the hypothesis that continuing anticoagulant therapy during polypectomy is non-inferior to interrupting it, with a non-inferiority margin set at 10%.
A total of 481 patients will be enrolled, with 241 patients per group. The intervention consists of maintaining ongoing anticoagulant treatment without modification before the procedure. This trial is classified as a low-intervention study according to regulatory guidelines and aims to provide evidence to optimize the management of anticoagulated patients undergoing colorectal polypectomy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: