PeriOperative Bridging - Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents

• ClinicalTrials.gov Identifier: NCT00606151
• Recruitment Status: Terminated
• First Posted: February 1, 2008
• Last Update Posted: March 26, 2009
• Sponsor: The Cleveland Clinic
• Information provided by: The Cleveland Clinic

Study Description

Brief Summary:

The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is as safe and effective at preventing clot formation in your stented artery as compared in people who have stopped clopidogrel prior to surgery.

Condition or disease
Stent Thrombosis

Detailed Description:

Stent thrombosis continues to be associated with a high rate of death or myocardial infarction. While this risk has been ameliorated through the use of the oral antiplatelet agent clopidogrel, there is a small but important subset of patients who will require discontinuation of clopidogrel due to unplanned or emergency surgery. These patients are exposed to a high risk of stent thrombosis during this time period. It is not known whether a strategy of intravenous antiplatelet therapy to "bridge" these patients is effective at preventing the morbidity related to stent thrombosis in the perioperative period. We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Study Design

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Short-Term Outcomes of Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents
• Study Start Date: January 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. stent thrombosis [ Time Frame: hospitalization ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Criteria

Inclusion Criteria:

• Aged 18 years or greater, able to give consent
• DES implantation < or = 6 months prior to admission
• Undergoing an invasive surgical procedure that will require cessation of clopidogrel therapy for >48 hours

Exclusion Criteria:

• Age < 18 years
• Refusal to give consent
• Surgical procedure performed without discontinuation of clopidogrel therapy (or < 48h of clopidogrel cessation)
• Ongoing anticoagulant therapy other than aspirin (i.e. warfarin, ticlopidine)

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Matthew (Casey) Becker, MD; The Cleveland Clinic

More Information

• Responsible Party: Matthew Becker, MD, Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00606151
• Other Study ID Numbers: 07669; 07669
• First Posted: February 1, 2008
• Last Update Posted: March 26, 2009
• Last Verified: March 2009

Keywords provided by The Cleveland Clinic:

drug eluding stents; perioperative bridging; Stents

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases