Recruiting

Bivalirudin vs. Heparin/ GP IIB/IIA

Sponsor:

Gold, Herman K., MD

Code:

NCT00476944

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Coronary Intervention (PCI)

Study Details

Brief summary:

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.

Conditions

Coronary Artery Disease

Study ID

NCT00476944

Start date

Sep, 2006

Status verified date

May, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Interventions

Percutaneous Coronary Intervention (PCI)

Primary outcome measure

  • Number of patients who require a vascular groin ultrasound or abdominal CT. [ Time Frame: undefined ]
  • Record occurrence of pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or femoral vein or arterial thrombosis [ Time Frame: undefined ]
  • Record presence of hematoma and size if applicable. [ Time Frame: undefined ]
  • Record hemoglobin drop >3g/dl with over bleeding. Also, record any red cell transfusion due to catheterization related bleeding. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Maureen Daher, RN

617-726-7400MDAHER@PARTNERS.ORG

Jae S Oh, BSc

617-643-0456JSOH@PARTNERS.ORG

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Herman K Gold, MD

More Information

Sponsor

Gold, Herman K., MD

Last update posted

May 22, 2007

Last verified

May, 2007

Keywords

  • CAD
  • Coronary Artery Disease
  • Angiomax
  • Bivalirudin
  • PCI
  • MAVE
  • Heparin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Gold, Herman K., MD on 2007-05-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.