Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)NCT00290849
ImproveR International (BI-001-IM)
An observational study of Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI), run by Nycomed at 1 site in Denmark.
Trial summary
The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives; examine the aspects of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Bivalirudin
- How many people
- 4,000 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Sep 2007
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- > 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: European Registry of Consecutive Patients Undergoing PCI Evaluating the Use of the Thrombin-specific Anticoagulant Bivalirudin With Focus on Patient Selection, Convenience and Safety Aspects.
The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives;
- examine the aspects of safety and effectiveness of bivalirudin
- gain experience regarding the characteristics of patients in bivalirudin treatment
- evaluate the handling of bivalirudin and its practicality
- Conditions
- Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
- Being tested
- Bivalirudin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following;
•examine the aspects of safety and effectiveness of bivalirudin
•gain experience regarding the characteristics of patients in bivalirudin treatment
•evaluate the handling of bivalirudin and its practicality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startMar 2005
- Primary completionJun 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290849
- Sponsor's protocol ID
- BI-001-IM
- Status last verified
- Apr 2010
- First submitted
- 14 Dec 2005
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry of Consecutive Patients Undergoing PCI Evaluating the Use of the Thrombin-specific Anticoagulant Bivalirudin With Focus on Patient Selection, Convenience and Safety Aspects.
- ClinicalTrials.gov ID
- NCT00290849
- Acronym / sponsor ID
- BI-001-IM
- Conditions
- Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Feb 2006 (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 objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives;
- examine the aspects of safety and effectiveness of bivalirudin
- gain experience regarding the characteristics of patients in bivalirudin treatment
- evaluate the handling of bivalirudin and its practicality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- > 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalirudin | Drug | – |
Primary outcome
To assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following;
•examine the aspects of safety and effectiveness of bivalirudin
•gain experience regarding the characteristics of patients in bivalirudin treatment
•evaluate the handling of bivalirudin and its practicality.
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 7 May 2012.
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.
Nycomed Clinical Trial Operations study chair
Headquaters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI), run by Nycomed at 1 site in Denmark.
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 1 inclusion and 1 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 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
To assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following;. The study lists 4 primary outcomes in all. 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 7 May 2012.