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Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320229
First Posted: May 3, 2006
Last Update Posted: May 16, 2006
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.
Collaborator:
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
Information provided by:
Azienda Sanitaria Ospedaliera
  Purpose
The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Condition Intervention Phase
Coronary Disease Myocardial Infarction Drug: abciximab Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Ospedaliera:

Estimated Enrollment: 84
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
Detailed Description:
Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presenting with unstable angina
  • presenting with acute myocardial infarction
  • eligibility for percutaneous coronary intervention

Exclusion Criteria:

  • presenting with cardiogenic shock
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00320229


Locations
Italy
Cardiologia 2 - Emodinamica - Ospedale Maggiore
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Sanitaria Ospedaliera
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
Investigators
Principal Investigator: Mara Sansa Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy
  More Information

ClinicalTrials.gov Identifier: NCT00320229     History of Changes
Other Study ID Numbers: ABCX-LD
First Submitted: April 18, 2006
First Posted: May 3, 2006
Last Update Posted: May 16, 2006
Last Verified: January 2006

Keywords provided by Azienda Sanitaria Ospedaliera:
angioplasty
stent
abciximab
Platelet Glycoprotein GPIIb-IIIa Complex
myocardial infarction

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