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OpenTrials
Completed

NCT Number: NCT00290849

ImproveR International (BI-001-IM)

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bivalirudin

Drug

Primary outcomes

  1. 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;

  2. •examine the aspects of safety and effectiveness of bivalirudin

  3. •gain experience regarding the characteristics of patients in bivalirudin treatment

  4. •evaluate the handling of bivalirudin and its practicality.

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Feb 13, 2006
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.