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Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery

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clinicaltrials.gov/study/NCT00653601
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT006536010
Health Conditions in Trial
Thrombosis
Thrombosis
0
Bleeding
Bleeding
0
Trial Recruitment Size
200
Trial Sponsor
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
0
Clinical Trial Start Date
2008
0
Primary Completion Date
2011
0
Study Completion Date
2011
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Case-Control0
Observational Study Perspective
Prospective0
Participating Facility
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
0
Official Name
Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery0
Last Updated
September 4, 2009
0
Study summary

Patients who have undergone placement of coronary stents require dual antiplatelet therapy with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of these patients will require surgery while on dual antiplatelet therapy. This poses a challenge because being on Plavix is associated with higher risks of perioperative bleeding, but stopping Plavix puts patients at increased risk for in-stent thrombosis. Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to surgery to prevent bleeding complications. However, there are no universal recommendations for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk perioperative period. Although these agents should be beneficial based on theory, there is currently no published data on their effectiveness for this purpose. The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis without increasing the risk of perioperative bleeding.

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