Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 implantation. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined up to one year after enrollment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LifeBridge Health
• Treatments: Bivalirudin; Eptifibatide; Hirudins; Thrombin

Criteria

Inclusion Criteria:

• Subjects (men or women) aged ³ 18

• Patients undergoing elective coronary stenting (200 patients)

Exclusion Criteria:

• 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.