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NCT00320229 Clinical Trial

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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00320229
Other study ID # ABCX-LD
Secondary ID
Status Terminated
Phase Phase 4
First received April 18, 2006
Last updated May 15, 2006
Start date December 2004
Est. completion date July 2005

Study information
Verified date January 2006
Source Azienda Sanitaria Ospedaliera
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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

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).

Recruitment information / eligibility
Status Terminated
Enrollment 84
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- presenting with unstable angina

- presenting with acute myocardial infarction

- eligibility for percutaneous coronary intervention

Exclusion Criteria:

- presenting with cardiogenic shock

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• abciximab

Locations
Country Name City State
Italy Cardiologia 2 - Emodinamica - Ospedale Maggiore Novara

Sponsors (2)
Lead Sponsor Collaborator
Azienda Sanitaria Ospedaliera Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy

Country where clinical trial is conducted

Italy, 

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