NCT00290849

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 7, 2012

Status Verified

April 1, 2010

Enrollment Period

1.3 years

First QC Date

December 14, 2005

Last Update Submit

May 4, 2012

Conditions

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

Outcome Measures

Primary Outcomes (4)

  • 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.

Interventions

BivalirudinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • \> 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Interventions

bivalirudin

Study Officials

  • Nycomed Clinical Trial Operations

    Headquaters

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 14, 2005

First Posted

February 13, 2006

Study Start

March 1, 2005

Primary Completion

June 1, 2006

Study Completion

September 1, 2007

Last Updated

May 7, 2012

Record last verified: 2010-04

Locations

DK(1)