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ImproveR International (BI-001-IM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290849
First Posted: February 13, 2006
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Resource links provided by NLM:


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: September 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290849


Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00290849     History of Changes
Other Study ID Numbers: BI-001-IM
First Submitted: December 14, 2005
First Posted: February 13, 2006
Last Update Posted: May 7, 2012
Last Verified: April 2010

Additional relevant MeSH terms:
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants