Status:
UNKNOWN
Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin
Lead Sponsor:
LifeBridge Health
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantat...
Detailed Description
Percutaneous stent implantation has revolutionized the revascularization procedure for patients with obstructive coronary disease and angina. The major risk of coronary stenting, both during and after...
Eligibility Criteria
Inclusion
- Subjects (men or women) aged ³ 18
- Patients undergoing elective coronary stenting (200 patients)
Exclusion
- ST-segment elevation myocardial infarction within 48 hours prior to randomization
- Prior PCI within previous 4 weeks of randomization or planned staged PCI within the subsequent month.
- Cardiogenic shock
- \> 50% unprotected left main stenosis
- Any low molecular weight heparin within the prior 12 hours
- Treatment with any P2Y12 blocker (Plavix or Ticlid) within the previous 14 days before randomization
- Treatment with any platelet GPIIb/IIIa inhibitor within the previous 30 days before randomization
- Concurrent treatment with warfarin
- History of bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization.
- History of hemorrhagic stroke at any time, or stroke or TIA of any etiology within 30 days of randomization.
- Major surgery within 6 weeks prior to randomization.
- Known platelet count of \<100,000/mm3.
- PT \> 1.5 X control
- HCT \< 25%
- Known allergy or contraindication to eptifibatide, heparin, aspirin or plavix.
- Participation in a study of experimental therapy or device 30 days prior to randomization.
- Creatinine level of greater than 2.0 mg/dl or a creatinine clearance \<30mL
- Known history of alcohol or drug abuse
- Pregnant women or women of child bearing potential not using an acceptable method of contraception.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00370045
Start Date
March 1 2006
Last Update
August 30 2006
Active Locations (1)
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1
Sinai Hospital
Baltimore, Maryland, United States, 21215