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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01960296
First received: October 8, 2013
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Clopidogrel
Drug: Clopidogrel
Drug: Discontinue Clopidogrel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Development of myocardial infarction or thrombosis [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel
Continue home dose of clopidogrel into surgery
Drug: Clopidogrel
Continue home dose of clopidogrel into surgery
Active Comparator: Discontinue
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Drug: Discontinue Clopidogrel
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960296

Contacts
Contact: Bryan Gershan, MD 212-241-4921 bryangershen@gmail.com
Contact: Celia M Divino, MD 212-241-3348 celia.divino@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Edward Chu, MD    407-616-7890    edward.chu@mountsinai.org   
Principal Investigator: Celia M Divino, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Celia M Divino, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01960296     History of Changes
Other Study ID Numbers: GCO 10-1067
Study First Received: October 8, 2013
Last Updated: October 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
clopidogrel
general surgery

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014