Clopidogrel | Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
Clopidogrel research study
What is the primary objective of this study?
Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.
Who is eligible to participate?
Inclusion Criteria: - taking clopidogrel - undergoing general surgery - cleared by both cardiologist and surgery for randomized arm Exclusion Criteria: - previous history of bleeding complications/bleeding disposition - no capacity to consent
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:ClopidogrelContinue home dose of clopidogrel into surgery
Drug:Discontinue ClopidogrelDiscontinue home dose of clopidogrel one week before surgery. Resume after surgery.
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 home dose of clopidogrel into surgery
DiscontinueDiscontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Start Date: January 2012
Completed Date: May 2013
Phase: Phase 2
Primary Outcome: Bleeding-related Re-hospitalization
Secondary Outcome: Procedure Estimated Blood Loss
Study sponsors, principal investigator, and references
Principal Investigator: Celia M Divino, MD
Lead Sponsor: Icahn School of Medicine at Mount Sinai
Collaborator: Doris Duke Charitable Foundation
Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23.
Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20.