Utilisation of Angiox® in European Practice (EURO-vision)
This study has been completed.
Sponsor:
The Medicines Company
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 16, 2013