Polypectomy in Patients Taking Dual Antiplatelet Agents

Not Applicable

• Conditions: Colonic Polyps
• Interventions: Drug: Continue thienopyridine; Drug: Discontinue thienopyridine

• Registration Number: NCT02865824
• Lead Sponsor: Incheon St.Mary's Hospital

Brief Summary

Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding risks during polypectomy and if b) discontinuation of these drugs increases the occurence of thromboembolic events.

Detailed Description

Patients taking dual antiplatelets (DAT) and who visited for colonoscopy were eligible for enrollment in this study. On enrollment, patients were randomized to two groups. One group continued DAT and the other group discontinued antiplatelets (i.e. clopidogrel, ticagrelor, prasugrel) for 7 days before colonoscopy. If polyps (≤1 cm) were observed during colonoscopy, they were removed by cold snare polypectomy. The primary aim was to compared the delayed bleeding rates of the two groups.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-15
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• patients over the age of 20 years undergoing routine colonoscopy
• patients who are taking DAT (dual antiplatelet therapy)

Exclusion Criteria

• patients not abiding to the study protocol
• history of inflammatory bowel disease
• severe comorbidities
• American Society of Anesthesiology class III or more
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continue thienopyridine	Continue thienopyridine	Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.
Discontinue thienopyridine	Discontinue thienopyridine	Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.

Primary Outcome Measures

Name	Time	Method
Delayed bleeding requiring hemostasis after polypectomy	2 weeks

Secondary Outcome Measures

Name	Time	Method
immediate bleeding requiring hemostasis after polypectomy	1 day

Trial Locations

Locations (1)

Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of