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

January 18, 2012 updated by: The Medicines Company

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2019

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • Centre Hospitalier Universitaire de Caen
  • Germany
      • Rostock, Germany, D-18057
        • Medizinische Klinik I Kardiologie/Pneumologie/Internistische

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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®.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Medicines Company

Investigators

  • Principal Investigator: Christoph Nienaber, Prof.
  • Principal Investigator: Martial Hamon, Prof

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMC-BIV-08-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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