Intravenous Versus Intracoronary Use of Abciximab
Intravenous vs. Intracoronary Use of Abciximab
1 other identifier
interventional
355
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 10, 2011
February 1, 2009
2.9 years
May 22, 2008
August 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death, TVR, bleeding, stroke
30 days and 1 year
Study Arms (2)
2
ACTIVE COMPARATORIntravenous bolus Abciximab.
Abciximab
ACTIVE COMPARATORIntracoronary bolus abciximab.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Cardiology, Gentofte University Hospital
Hellerup, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Iversen, MD
Gentofte University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 28, 2008
Study Start
January 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
August 10, 2011
Record last verified: 2009-02