Gastrointestinal Bleeding | Uninterrupted Clopidogrel Therapy Before Elective Colonoscopy Will Increase the Risk of Post-polypectomy Bleeding
Gastrointestinal Bleeding research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. On regular treatment with clopidogrel alone or in combination with other anti-platelet drugs (e.g. aspirin) 2. Elective colonoscopy for asymptomatic screening of bowel cancer or investigation of bowel symptoms (e.g. altered bowel habit, rectal bleeding, anemia, polyp follow-up) 3. Age ≥ 18 4. Written informed consent Exclusion Criteria: 1. Coronary stent of any type placed within 30 days 2. Cardiac-vascular event within 3 months 3. Drug-eluting coronary stent placed within 6 months 4. Terminal illness 5. Concomitant use of anticoagulants 6. Congenital or acquired bleeding diathesis showing clinical bleeding tendency (e.g. hemophilia, decompensated cirrhosis) 7. Pregnancy or women of child-bearing age without regular use of contraception
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:clopidogrelClopidogrel 7 days prior to the endoscopic procedure (Colonoscopy)
Other:PlaceboPlacebo for 7 days prior to the endoscopic procedure (Colonoscopy)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ClopidogrelContinue clopidogrel for 7 days prior to the endoscopic procedure
PlaceboPlacebo daily for 7 days prior to the endoscopic procedure
Start Date: February 2012
Completed Date: April 2018
Phase: Phase 4
Primary Outcome: Delayed post-polypectomy bleeding
Secondary Outcome: Immediate post-polypectomy bleeding
Study sponsors, principal investigator, and references
Principal Investigator: Francis KL Chan, MD
Lead Sponsor: Chinese University of Hong Kong