Stable Angina (SA)EURO-visionNCT01011504
Utilisation of Angiox® in European Practice
An observational study of Stable Angina (SA) and NSTE-ACS (NSTEMI and UA), run by The Medicines Company at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Angina (SA), NSTE-ACS (NSTEMI and UA), STEMI (STE-ACS)
- How many people
- 2,019 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately, 2,000 patients will be included at centres throughout Europe
Who may be able to join
- 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
Who cannot join
- 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®.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Medizinische Klinik I Kardiologie/Pneumologie/Internistische
Rostock, D-18057
About this study
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.
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
- Medical subject headings
- Angina, Stable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered
Measured: from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).
Secondary outcomes (1)
Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events
Measured: measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina (SA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Nienaber, Prof., Principal investigatorMartial Hamon, Prof, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011504
- Sponsor's protocol ID
- TMC-BIV-08-02
- Acronym
- EURO-vision
- Status last verified
- Jan 2012
- First submitted
- 10 Nov 2009
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01011504
- Acronym / sponsor ID
- EURO-vision / TMC-BIV-08-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,019 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately, 2,000 patients will be included at centres throughout Europe
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Related trials for Stable Angina (SA)
Recruiting
Breaking Fasts Ahead of Cardiac Caths
Stable Angina (SA), Unstable Angina (UA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Nienaber, Prof. principal investigator
Martial Hamon, Prof principal investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina (SA) and NSTE-ACS (NSTEMI and UA), run by The Medicines Company at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.