Back to resultsPolypectomy in Patients Taking Dual Antiplatelet Agents
Primary Purpose
Colonic Polyps
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Continue thienopyridine
Discontinue thienopyridine
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps focused on measuring Colonoscopy
Eligibility Criteria
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
Sites / Locations
- Incheon St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Continue thienopyridine
Discontinue thienopyridine
Arm Description
Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.
Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.
Outcomes
Primary Outcome Measures
Delayed bleeding requiring hemostasis after polypectomy
Secondary Outcome Measures
immediate bleeding requiring hemostasis after polypectomy
Full Information
NCT ID
NCT02865824
First Posted
August 1, 2016
Last Updated
August 16, 2016
Sponsor
Incheon St.Mary's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02865824
Brief Title
Polypectomy in Patients Taking Dual Antiplatelet Agents
Official Title
Effects of Antiplatelets Discontinuation in Patients Receiving Polypectomy: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continue thienopyridine
Arm Type
Active Comparator
Arm Description
Patients continue dual antiplatelet therapy (DAT) before colonoscopy and all polyps are removed by cold snare polypectomy.
Arm Title
Discontinue thienopyridine
Arm Type
Experimental
Arm Description
Patients discontinue thienopyridines for 1 week before colonoscopy and all polyps are removed by cold snare polypectomy.
Intervention Type
Drug
Intervention Name(s)
Continue thienopyridine
Other Intervention Name(s)
DAT group
Intervention Description
Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
Intervention Type
Drug
Intervention Name(s)
Discontinue thienopyridine
Other Intervention Name(s)
Aspirin group
Intervention Description
Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy
Primary Outcome Measure Information:
Title
Delayed bleeding requiring hemostasis after polypectomy
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
immediate bleeding requiring hemostasis after polypectomy
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Sung Kim, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31599746
Citation
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.
Results Reference
derived
Learn more about this trial
Polypectomy in Patients Taking Dual Antiplatelet Agents
We'll reach out to this number within 24 hrs