NCT00468702

Brief Summary

This study will measure the efficacy and safety of an early postoperative anticoagulation self-management program, using the CoaguChek S device, in patients undergoing mechanical valve replacements. Patients will be randomized into a study group (self-management) or a control group (physician management).

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

First QC Date

May 2, 2007

Last Update Submit

November 1, 2016

Conditions

Cardiovascular Abnormalities

Interventions

CoaguChek SDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-70 years of age;
  • recipient of a mechanical heart valve (aortic and/or mitral), +/- CABG, +/- postoperative atrial fibrillation.

You may not qualify if:

  • recipient of a bioprosthetic valve;
  • post-operative thrombotic events;
  • pre-operative utilization of oral anticoagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ottawa, Canada

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

September 1, 2007

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CA(1)