Uninterrupted Clopidogrel Therapy Before Elective Colonoscopy Will Increase the Risk of Post-polypectomy Bleeding

NCT01806090 | Completed Phase 4

• 1 other identifier: UCP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, randomized trial aims to evaluate whether uninterrupted anti-platelet therapy (clopidogrel) will increase the risk of bleeding associated with removal of polyp during colonoscopy in patients with coronary artery disease.

Conditions

Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Delayed post-polypectomy bleeding

  The primary endpoint is delayed post-polypectomy bleeding. The latter is defined as rectal bleeding, starting after the colonoscope has been retracted from the anus to 30 days after the procedure.

  30 days post-colonoscopy

Secondary Outcomes (2)

• Immediate post-polypectomy bleeding

  Within 5 minutes after polypectomy

• Serious Cardiothrombotic events

  6 months after colonoscopy

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Continue clopidogrel for 7 days prior to the endoscopic procedure

Drug: clopidogrel

Placebo

PLACEBO COMPARATOR

Placebo daily for 7 days prior to the endoscopic procedure

Other: Placebo

Interventions

clopidogrel DRUG

Clopidogrel 7 days prior to the endoscopic procedure (Colonoscopy)

Also known as: Plavix

Clopidogrel

Placebo OTHER

Placebo for 7 days prior to the endoscopic procedure (Colonoscopy)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On regular treatment with clopidogrel alone or in combination with other anti-platelet drugs (e.g. aspirin)
• Elective colonoscopy for asymptomatic screening of bowel cancer or investigation of bowel symptoms (e.g. altered bowel habit, rectal bleeding, anemia, polyp follow-up)
• Age ≥ 18
• Written informed consent

You may not qualify if:

• Coronary stent of any type placed within 30 days
• Cardiac-vascular event within 3 months
• Drug-eluting coronary stent placed within 6 months
• Terminal illness
• Concomitant use of anticoagulants
• Congenital or acquired bleeding diathesis showing clinical bleeding tendency (e.g. hemophilia, decompensated cirrhosis)
• Pregnancy or women of child-bearing age without regular use of contraception

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• Chan FKL, Kyaw MH, Hsiang JC, Suen BY, Kee KM, Tse YK, Ching JYL, Cheong PK, Ng D, Lam K, Lo A, Lee V, Ng SC. Risk of Postpolypectomy Bleeding With Uninterrupted Clopidogrel Therapy in an Industry-Independent, Double-Blind, Randomized Trial. Gastroenterology. 2019 Mar;156(4):918-925.e1. doi: 10.1053/j.gastro.2018.10.036. Epub 2018 Oct 25.

  PMID: 30518511 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francis KL Chan, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 7, 2013
• Study Start: February 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CN (1)