Back to resultsHalf-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
Primary Purpose
Coronary Disease, Myocardial Infarction
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
abciximab
Sponsored by
About this trial
This is an interventional trial for Coronary Disease focused on measuring angioplasty, stent, abciximab, Platelet Glycoprotein GPIIb-IIIa Complex, myocardial infarction
Eligibility Criteria
Inclusion Criteria: presenting with unstable angina presenting with acute myocardial infarction eligibility for percutaneous coronary intervention Exclusion Criteria: presenting with cardiogenic shock
Sites / Locations
- Cardiologia 2 - Emodinamica - Ospedale Maggiore
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00320229
First Posted
April 18, 2006
Last Updated
May 15, 2006
Sponsor
Azienda Sanitaria Ospedaliera
Collaborators
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
1. Study Identification
Unique Protocol Identification Number
NCT00320229
Brief Title
Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Sanitaria Ospedaliera
Collaborators
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
4. Oversight
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Myocardial Infarction
Keywords
angioplasty, stent, abciximab, Platelet Glycoprotein GPIIb-IIIa Complex, myocardial infarction
7. Study Design
Study Phase
Phase 4
Enrollment
84 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
abciximab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
presenting with unstable angina
presenting with acute myocardial infarction
eligibility for percutaneous coronary intervention
Exclusion Criteria:
presenting with cardiogenic shock
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Sansa
Organizational Affiliation
Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiologia 2 - Emodinamica - Ospedale Maggiore
City
Novara
ZIP/Postal Code
28100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
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