Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01960296
First received: October 8, 2013
Last updated: November 4, 2015
Last verified: November 2015

October 8, 2013
November 4, 2015
January 2012
May 2013   (final data collection date for primary outcome measure)
Perioperative Bleeding Complications [ Time Frame: up to 90 days post op ] [ Designated as safety issue: Yes ]
Development of perioperative bleeding complications, including need for blood transfusions, hematoma, and bleeding requiring re-admission or re-operation
Same as current
Complete list of historical versions of study NCT01960296 on ClinicalTrials.gov Archive Site
Development of myocardial infarction or thrombosis [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Clopidogrel
  • Drug: Clopidogrel
    Continue home dose of clopidogrel into surgery
  • Drug: Discontinue Clopidogrel
    Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
  • Experimental: Clopidogrel
    Continue home dose of clopidogrel into surgery
    Intervention: Drug: Clopidogrel
  • Active Comparator: Discontinue
    Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
    Intervention: Drug: Discontinue Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01960296
GCO 10-1067
Yes
Not Provided
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Doris Duke Charitable Foundation
Principal Investigator: Celia M Divino, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP