ImproveR International (BI-001-IM) - Full Text View

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00290849

Purpose

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

Condition	Intervention
Thrombin-Specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)	Drug: Bivalirudin

MedlinePlus related topics: Blood Thinners

Drug Information available for: Bivalirudin

U.S. FDA Resources

Study Type:	Observational
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.

Further study details as provided by Nycomed:

Primary Outcome Measures:

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.

Estimated Enrollment:	4000
Study Start Date:	March 2005
Study Completion Date:	July 2007
Estimated Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

> 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290849

Locations

Denmark
Nycomed
Roskilde, Denmark, 4000

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

Study ID Numbers:	BI-001-IM
Study First Received:	December 14, 2005
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00290849
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Italy: The Italian Medicines Agency; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: Dutch Health Care Inspectorate; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency

Study placed in the following topic categories:

Thrombin
Bivalirudin

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009