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

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ClinicalTrials.gov Identifier: NCT00606151
Recruitment Status : Terminated (subject enrollment goals not met)
First Posted : February 1, 2008
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:

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
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. stent thrombosis [ Time Frame: hospitalization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606151


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     History of Changes
Other Study ID Numbers: 07669
First Posted: February 1, 2008    Key Record Dates
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