Comparing Bivalirudin Versus Heparin/ GP IIB/IIA in Patients Undergoing PCI

Status unconfirmed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use.

Key facts

Study ID: NCT00476944
Run by: Gold, Herman K., MD
Starts: 2006-09-01
Last updated by the study team: 2007-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must meet ALL of the following criteria:
The patients must be >18 years of age
Patients must have been referred for percutaneous coronary intervention (PCI)
Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
Treatment of lesions in native coronary vessels or bypass grafts requiring angioplasty or stenting.
Patient is willing to comply with the specified follow-up evaluation;
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.

You may not qualify if…

Patients will be excluded if ANY of the following conditions apply:
Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
Active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding within past 6 weeks; prior intracranial bleeding; or platelet count<100,000
Woman of child-bearing potential unless demonstrated negative pregnancy test
End Stage Renal Disease requiring hemodialysis
Recipient of heart transplant;
Current treatment with 1) intravenous unfractionated heparin or treatment with low molecular weight heparin within past 8 hours; 2)bivalirudin; 3)abciximab; 4)eptifibatide; or tirofiban
Ongoing need for warfarin or heparin therapy
Known allergies to aspirin, clopidogrel bisulfate (Plavix®) and/or heparin;
Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
Currently participating in an investigational drug or another device study;
Any contraindication to glycoprotein IIb/IIIa inhibitor (eptifibatide (Integrilin®)) or bivalirudin therapy;
Chronic or relapse/remitting hemolytic condition or pre-catheterization hematocrit<30 mg/dl
Unprotected left main coronary disease with >50% stenosis;
Platelet count <150,000

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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