ImproveR International (BI-001-IM)

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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290849
• Other study ID #: BI-001-IM
• Status: Completed
• Phase: N/A
• First received: December 14, 2005
• Last updated: May 4, 2012
• Start date: March 2005
• Est. completion date: September 2007

Study information

• Verified date: April 2010
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Dutch Health Care InspectorateNorway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: September 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bivalirudin

Locations

Country	Name	City	State
Denmark	Nycomed	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;
Primary	•examine the aspects of safety and effectiveness of bivalirudin
Primary	•gain experience regarding the characteristics of patients in bivalirudin treatment
Primary	•evaluate the handling of bivalirudin and its practicality.