Colonoscopy in patients taking the blood thinner Clopidogrel; Is stopping the treatment before removing polyps necessary.

Phase 1

• Conditions: Post polypectomy bleeding; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-000996-17-DK
• Lead Sponsor: Thomas Møller Jensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-26
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

•Patients referred to an elective colonoscopy at HRH (screening, symptom or control)
•In therapy with Clopidogrel (75 mg per day) alone or in combination with ASA
•The patient requires polypectomy of at least one sessile polyp = 20 mm, and no polyps >20 mm or pedunculated polyps are found
•The patient is categorised as at low risk of thrombotic events at the time of the diagnostic colonoscopy, assessed by the responsible doctor, according to the standard guidelines
•Age = 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion Criteria

•High-risk of thromboembolic event:
o< 6 weeks since uncomplicated coronary event with or without revascularization (Percutaneous coronary intervention (PCI)/bare-metal stent (BMS), coronary artery bypass grafting (CABG))
o< 3 months since uncomplicated coronary event with revascularization (PCI/drug-eluting stent (DES))
o<12 months since complicated coronary event (e.g. reinfarction, stent thrombosis)
o<1 month in stabile coronary artery disease (CAD) with revascularization (PCI/BMS)
o<3 month since stroke or transient ischemic attack
•Inability to provide informed consent (e.g. mental impairment)
•Not able to read and understand Danish
•Cannot be reached by telephone for follow-up
•In therapy with other antithrombotic medication (except ASA)) such as vitamin-K antagonists (e.g. Warfarin, Phenprocoumon) or NOAK´s (e.g. Pradaxa®, Xarelto®)
•American Society of Anaesthesiology classification class IV
•Fertile women NOT taking anticonception (spiral or hormones). Menopause is defined as at least 12 months of no menstruation before enrollment
•Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the risk of post polypectomy bleeding after polypectomy of sessile polyps = 20 mm in diameter in patients on uninterrupted Clopidogrel therapy before polypectomy;Secondary Objective: Not applicable;Primary end point(s): •Clinically significant immediate post polypectomy bleeding: defined as bleeding observed by the endoscopist during the procedure persisting more than 5 minutes despite irrigation and use of adrenalin injection or endo-clips<br>•Clinically significant delayedpost polypectomy bleeding: defined as bleeding that required hospitalisation, red cell transfusion or endoscopic re-evaluation in the period after the end of the procedure and up to 30 days after the procedure.<br>;Timepoint(s) of evaluation of this end point: After inclusion of 90 patients an interim analysis will be conducted and after inclusion and follow-up of all 180 participants

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Visually observed passage per rectum of red or dark blood in the stool – observed by the patient in the period after the end of the procedure and up to 30 days after the procedure.<br>•Contact with healthcare services (incl. doctor on call), that did not lead to admission to the hospital, because of bleeding per rectum in the period after the end of the procedure and up to 30 days after the procedure.<br>•Thromboembolic events occurring in the period 5 days before the procedure and up to 30 days after the procedure<br>;Timepoint(s) of evaluation of this end point: After inclusion of 90 patients an interim analysis will be conducted and after inclusion and follow-up of all 180 participants