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
  Purpose

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
Stent Thrombosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Short-Term Outcomes of Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • stent thrombosis [ Time Frame: hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Matthew Becker, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00606151     History of Changes
Other Study ID Numbers: 07669, 07669
Study First Received: January 22, 2008
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
drug eluding stents
perioperative bridging
Stents

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014