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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on October 16, 2014