Intravenous Versus Intracoronary Use of Abciximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00685464
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : August 10, 2011
Information provided by:
University Hospital, Gentofte, Copenhagen

Brief Summary:
The aim of this study is to investigate wether intracoronary use of bolus Abciximab is superior to intravenous bolus in patients undergoing percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Atherosclerosis Ischemic Heart Disease Drug: Abciximab Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous vs. Intracoronary Use of Abciximab
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
Intravenous bolus Abciximab.
Drug: Abciximab
Active Comparator: Abciximab
Intracoronary bolus abciximab.
Drug: Abciximab

Primary Outcome Measures :
  1. Death, TVR, bleeding, stroke [ Time Frame: 30 days and 1 year ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Usually inclusion criteria for Abciximab, that is:
  • Adjunct to PCI for the prevention of cardiac ischemic complications:

    • In patients undergoing PCI
    • In patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours

Exclusion Criteria:

Usually exclusion criteria for Abciximab, that is:

  • Active internal bleeding, recent (within 6 weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
  • History of cerebrovascular accident (CVA) within 2 years, or CVA with a significant residual neurological deficit
  • Bleeding diathesis
  • Administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia (<100,000 cells/µL)
  • Recent (within 6 weeks) major surgery or trauma
  • Intracranial neoplasm
  • Arteriovenous malformation, or aneurysm
  • Severe uncontrolled hypertension
  • Presumed or documented history of vasculitis
  • Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention
  • Known hypersensitivity to any component of this product or to murine proteins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00685464

Dept. of Cardiology, Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Principal Investigator: Allan Iversen, MD Gentofte University Hospital

Responsible Party: Jan Skov Jensen, MD, Ph.D, DMSc, Gentofte University Hospital Identifier: NCT00685464     History of Changes
Other Study ID Numbers: UHGentofte
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: February 2009

Keywords provided by University Hospital, Gentofte, Copenhagen:

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs