Recruiting

Clopidogrel & Bivalirudin

Sponsor:

LifeBridge Health

Code:

NCT00370045

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bivalirudin with and without eptifibatide

Study Details

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 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.

Conditions

Coronary Artery Disease

Study ID

NCT00370045

Start date

Mar, 2006

Status verified date

Aug, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Bivalirudin with and without eptifibatide

Primary outcome measure

  • Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

kevin p bliden, BS

4106014795kbliden@lifebridgehealth.org

joe Dichiara, BS

4106010619jdichiar@lifebridgehealth.org

Locations

Sinai Hospital

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Kevin P Bliden, BS

410-601-4795kbliden@lifebridgehealth.org

Principal Investigator:

Paul A Gurbel, MD

More Information

Sponsor

LifeBridge Health

Last update posted

Aug 30, 2006

Last verified

Aug, 2006

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2006-08-30.