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
  Purpose

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


Condition
Stable Angina (SA)
NSTE-ACS (NSTEMI and UA)
STEMI (STE-ACS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.

Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2019
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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®.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011504

Locations
France
Centre Hospitalier Universitaire de Caen
Caen, France, 14033
Germany
Medizinische Klinik I Kardiologie/Pneumologie/Internistische
Rostock, Germany, D-18057
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Christoph Nienaber, Prof.
Principal Investigator: Martial Hamon, Prof
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01011504     History of Changes
Other Study ID Numbers: TMC-BIV-08-02
Study First Received: November 10, 2009
Last Updated: January 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 16, 2014