ImproveR International (BI-001-IM)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00290849
First received: December 14, 2005
Last updated: May 4, 2012
Last verified: April 2010
  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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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:

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

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00290849     History of Changes
Other Study ID Numbers: BI-001-IM
Study First Received: December 14, 2005
Last Updated: May 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014