Utilisation of Angiox® in European Practice

Completed

• Conditions: Stable Angina (SA); NSTE-ACS (NSTEMI and UA); STEMI (STE-ACS)

• Registration Number: NCT01011504
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2019

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Caen; 🇫🇷 Caen, France

Medizinische Klinik I Kardiologie/Pneumologie/Internistische; 🇩🇪 Rostock, Germany