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

Clopidogrel Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960296
• Other study ID #: GCO 10-1067
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2013
• Last updated: November 4, 2015
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Clopidogrel

Intervention

Drug:
• Clopidogrel
Continue home dose of clopidogrel into surgery
• Discontinue Clopidogrel
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Bleeding Complications	Development of perioperative bleeding complications, including need for blood transfusions, hematoma, and bleeding requiring re-admission or re-operation	up to 90 days post op	Yes
Secondary	Development of myocardial infarction or thrombosis		up to 90 days	No