Half-Dose Intracoronary Abciximab Bolus Improves the Mort... | NCT00320229

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

NCT00320229

Sponsor

Azienda Sanitaria Ospedaliera

Status

Terminated

Last Update Posted

May 16, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Coronary Disease
Myocardial Infarction

Interventions

abciximab

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Apr 18, 2006

First Submission Date that Met QC Criteria

May 1, 2006

First Posted Date

May 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2006

Last Update Posted Date

May 16, 2006Estimated

Name	Class
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy	UNKNOWN

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
abciximab	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

presenting with cardiogenic shock

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mara Sansa	Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiologia 2 - Emodinamica - Ospedale Maggiore		Novara		28100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077284	Abciximab

Ancestor Terms

ID	Term
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided