NCT00257751

Brief Summary

Clopidogrel (Plavix), a platelet ADP receptor antagonist, has become the standard of care to prevent thrombosis in interventional cardiology and is increasingly being used in unstable angina and NSTEMI. An increasing number of patients are referred to emergent or urgent CABG, and several studies, as well as our own experience, have shown that preoperative administration of irreversible platelets inhibitors increase the risk of bleeding complications following CABG.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable coronary-artery-disease

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, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2009

Enrollment Period

3.7 years

First QC Date

November 22, 2005

Last Update Submit

July 3, 2011

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • Perioperative bleeding

  • Blood transfusions

  • Reoperation

Secondary Outcomes (1)

  • Difference in costs related to low/high dose

Interventions

AprotininePROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
All coronary bypass operations in patients receiving Plavix within the last 7 days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Eivind Øvrum, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

March 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 6, 2011

Record last verified: 2009-03