Intravenous Versus Intracoronary Use of Abciximab

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00685464
First received: May 22, 2008
Last updated: August 9, 2011
Last verified: February 2009
  Purpose

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 Intervention
Atherosclerosis
Ischemic Heart Disease
Drug: Abciximab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous vs. Intracoronary Use of Abciximab

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Death, TVR, bleeding, stroke [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 355
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Intravenous bolus Abciximab.
Drug: Abciximab
Intravenous.
Active Comparator: Abciximab
Intracoronary bolus abciximab.
Drug: Abciximab
Intracoronary

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685464

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

No publications provided

Responsible Party: Jan Skov Jensen, MD, Ph.D, DMSc, Gentofte University Hospital
ClinicalTrials.gov Identifier: NCT00685464     History of Changes
Other Study ID Numbers: UHGentofte
Study First Received: May 22, 2008
Last Updated: August 9, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by University Hospital, Gentofte, Copenhagen:
Abciximab
Reo-Pro
Intracoronary
PCI

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Abciximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014