PeriOperative Bridging - Perioperative Anticoagulation in the Setting of Recent Intracoronary Drug Eluting Stents
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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 |
- 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) |
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 |
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.
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 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 June 17, 2013