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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01011504
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
The Medicines Company

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

Condition or disease

Study Type : Observational
Actual Enrollment : 2019 participants
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.
Study Start Date : May 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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) ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately, 2,000 patients will be included at centres throughout Europe

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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01011504

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

Responsible Party: The Medicines Company Identifier: NCT01011504     History of Changes
Other Study ID Numbers: TMC-BIV-08-02
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms