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

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clopidogrel

Intervention: Clopidogrel (Drug); Discontinue Clopidogrel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Icahn School of Medicine at Mount Sinai

Official(s) and/or principal investigator(s):
Celia M Divino, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai

Overall contact:
Bryan Gershan, MD, Phone: 212-241-4921, Email: bryangershen@gmail.com

Summary

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.

Clinical Details

Official title: Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Perioperative Bleeding Complications

Secondary outcome: Development of myocardial infarction or thrombosis

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Bryan Gershan, MD, Phone: 212-241-4921, Email: bryangershen@gmail.com

Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting
Edward Chu, MD, Phone: 407-616-7890, Email: edward.chu@mountsinai.org
Celia M Divino, MD, Principal Investigator
Additional Information

Starting date: January 2012
Last updated: October 23, 2014

Page last updated: August 23, 2015

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