Polypectomy in Patients Taking Dual Antiplatelet Agents

August 16, 2016 updated by: Joon Sung Kim, Incheon St.Mary's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Continue thienopyridine
Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.
Drug: Continue thienopyridine
Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
Other Names:
  • DAT group
EXPERIMENTAL: Discontinue thienopyridine
Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.
Drug: Discontinue thienopyridine
Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy
Other Names:
  • Aspirin group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delayed bleeding requiring hemostasis after polypectomy
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
immediate bleeding requiring hemostasis after polypectomy
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incheon St.Mary's Hospital

Investigators

  • Principal Investigator: Joon Sung Kim, MD, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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