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Clinical Trials/NCT00290849
NCT00290849CompletedNot Applicable

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.

Nycomed1 site in 1 country4,000 target enrollmentStarted: March 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Nycomed
Enrollment
4,000
Locations
1
Primary Endpoint
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;

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nycomed
Sponsor Class
Industry

Study Sites (1)

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