Utilisation of Angiox® in European Practice
EURO-vision
A Registry Study to Determine Utilisation Patterns in Patients Receiving Angiox®, and Collect Descriptive Safety and Outcome Data to Inform the Risk Management Strategy for Europe.
1 other identifier
observational
2,019
2 countries
2
Brief Summary
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 19, 2012
January 1, 2012
1.4 years
November 10, 2009
January 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered
from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).
Secondary Outcomes (1)
Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events
measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days)
Eligibility Criteria
Approximately, 2,000 patients will be included at centres throughout Europe
You may qualify if:
- Eligible for, and receive treatment with Angiox®.
- Willing and able to provide written informed consent to the use of their data in accordance with relevant local Data Protection laws, policies and regulations
You may not qualify if:
- Participation in other interventional clinical research studies involving the evaluation of investigational drugs, including Angiox®, or devices at the time of enrolment.
- Patients not eligible for treatment for Angiox®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Universitaire de Caen
Caen, 14033, France
Medizinische Klinik I Kardiologie/Pneumologie/Internistische
Rostock, D-18057, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Nienaber, Prof.
- PRINCIPAL INVESTIGATOR
Martial Hamon, Prof
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
January 19, 2012
Record last verified: 2012-01