Polypectomy in Patients Taking Dual Antiplatelet Agents

Colonic Polyps Clinical Trial

Official title:

Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02865824
• Other study ID #: CMC
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 16, 2016
• Start date: January 2016
• Est. completion date: March 2019

Study information

• Verified date: August 2016
• Source: Incheon St.Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

Drug:
• Continue thienopyridine
Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
• Discontinue thienopyridine
Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed bleeding requiring hemostasis after polypectomy		2 weeks	Yes
Secondary	immediate bleeding requiring hemostasis after polypectomy		1 day	Yes