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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00606151

Enrollment

Registered

2008-02-01

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stent Thrombosis

Keywords

drug eluding stents, perioperative bridging, Stents

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
stent thrombosis	hospitalization

Countries

United States

Outcome results