NCT01647568

Brief Summary

At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy. Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
715

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

July 19, 2012

Last Update Submit

July 19, 2012

Conditions

Post-polypectomy BleedingAnti-platelet TherapyColonoscopy

Study Arms (2)

Control

Patients who are not on any anti-platelet/anti-coagulant therapy and present to our lab for a elective colonoscopy.

Thienopyridine Users

Patients on Clopidogrel or prasugrel when they present for an elective colonoscopy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the GI lab for elective colonoscopy.

You may qualify if:

  • Patients presenting to the GI lab for elective colonoscopy

You may not qualify if:

  • Patients on Coumadin or other anti-coagulants
  • Patients with Inflammatory Bowel Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (1)

  • Feagins LA, Iqbal R, Harford WV, Halai A, Cryer BL, Dunbar KB, Davila RE, Spechler SJ. Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1325-32. doi: 10.1016/j.cgh.2013.02.003. Epub 2013 Feb 9.

    PMID: 23403011DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Gastroenterologist

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

US(1)