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

Stent Thrombosis Clinical Trial

Official title:

Short-Term Outcomes of Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00606151
• Other study ID #: 07669
• Secondary ID: 07669
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: March 25, 2009
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stent Thrombosis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stent thrombosis		hospitalization	No