NCT02865824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

August 1, 2016

Last Update Submit

August 16, 2016

Conditions

Colonic Polyps

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Delayed bleeding requiring hemostasis after polypectomy

    2 weeks

Secondary Outcomes (1)

  • immediate bleeding requiring hemostasis after polypectomy

    1 day

Study Arms (2)

Continue thienopyridine

ACTIVE COMPARATOR

Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.

Drug: Continue thienopyridine

Discontinue thienopyridine

EXPERIMENTAL

Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.

Drug: Discontinue thienopyridine

Interventions

Continue thienopyridineDRUG

Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy

Also known as: DAT group
Continue thienopyridine
Discontinue thienopyridineDRUG

Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy

Also known as: Aspirin group
Discontinue thienopyridine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

Location

Related Publications (1)

  • Won D, Kim JS, Ji JS, Kim BW, Choi H. Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines. Clin Transl Gastroenterol. 2019 Oct;10(10):e00091. doi: 10.14309/ctg.0000000000000091.

    PMID: 31599746DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Joon Sung Kim, MD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 15, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)