ImproveR International (BI-001-IM)

Completed

• Conditions: Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)

• Registration Number: NCT00290849
• Lead Sponsor: Nycomed

Brief 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 safety and effectiveness of bivalirudin

* gain experience regarding the characteristics of patients in bivalirudin treatment

* evaluate the handling of bivalirudin and its practicality

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Primary Completion: 2006-06
• Study Completion: 2007-09
• Status Verified: 2010-04
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark