Utilisation of Angiox® in European Practice

NSTE-ACS (NSTEMI and UA) Clinical Trial

— EURO-vision  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011504
• Other study ID #: TMC-BIV-08-02
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: January 18, 2012
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2019
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Caen	Caen
Germany	Medizinische Klinik I Kardiologie/Pneumologie/Internistische	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Yes
Secondary	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)	Yes