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

This study has been terminated.
(subject enrollment goals not met)
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00606151
First received: January 22, 2008
Last updated: March 25, 2009
Last verified: March 2009

January 22, 2008
March 25, 2009
January 2008
January 2009   (final data collection date for primary outcome measure)
stent thrombosis [ Time Frame: hospitalization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606151 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Stent Thrombosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
January 2009
January 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606151
07669, 07669
No
Matthew Becker, MD, Cleveland Clinic
The Cleveland Clinic
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Principal Investigator: Matthew (Casey) Becker, MD The Cleveland Clinic
The Cleveland Clinic
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP