NCT01960296

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

October 8, 2013

Results QC Date

March 17, 2017

Last Update Submit

April 28, 2017

Conditions

Clopidogrel

Keywords

clopidogrelgeneral surgery

Outcome Measures

Primary Outcomes (2)

  • Bleeding-related Re-hospitalization

    Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

    up to 90 days post op

  • Perioperative Bleeding Complications

    Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.

    up to 90 days postop

Secondary Outcomes (6)

  • Procedure Estimated Blood Loss

    up to 90 days postop

  • Procedure Time

    Day 1

  • Average Change in Hematocrit

    baseline and Day 1

  • Average Length of Hospital Stay

    up to 90 days

  • Same Day Discharged

    up to 90 days

  • +1 more secondary outcomes

Study Arms (2)

Clopidogrel

EXPERIMENTAL

Continue home dose of clopidogrel into surgery

Drug: Clopidogrel

Discontinue

ACTIVE COMPARATOR

Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Drug: Discontinue Clopidogrel

Interventions

ClopidogrelDRUG

Continue home dose of clopidogrel into surgery

Clopidogrel
Discontinue ClopidogrelDRUG

Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Discontinue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • taking clopidogrel
  • undergoing general surgery
  • cleared by both cardiologist and surgery for randomized arm

You may not qualify if:

  • previous history of bleeding complications/bleeding disposition
  • no capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

  • 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.

    PMID: 21422366BACKGROUND

  • 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.

    PMID: 27002953RESULT

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The major limitation of the study is its low sample size, making it underpowered to draw unequivocal conclusions.

Results Point of Contact

Title
Dr. Celia M. Divino
Organization
Icahn School of Medicine at Mount Sinai
celia.divino@mountsinai.org
212-241-5499

Study Officials

  • Celia M Divino, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 30, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-04

Locations

US(1)