Utilisation of Angiox® in European Practice (EURO-vision)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01011504
First received: November 10, 2009
Last updated: January 18, 2012
Last verified: January 2012

November 10, 2009
January 18, 2012
May 2009
October 2010   (final data collection date for primary outcome measure)
Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered [ Time Frame: from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01011504 on ClinicalTrials.gov Archive Site
Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events [ Time Frame: measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days) ] [ Designated as safety issue: Yes ]
Same as current
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Utilisation of Angiox® in European Practice
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.

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

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Approximately, 2,000 patients will be included at centres throughout Europe

  • Stable Angina (SA)
  • NSTE-ACS (NSTEMI and UA)
  • STEMI (STE-ACS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2019
December 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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®.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT01011504
TMC-BIV-08-02
No
The Medicines Company
The Medicines Company
Not Provided
Principal Investigator: Christoph Nienaber, Prof.
Principal Investigator: Martial Hamon, Prof
The Medicines Company
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP