NCT01392040

Brief Summary

The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

July 11, 2011

Last Update Submit

January 16, 2013

Conditions

Anticoagulated Patients

Outcome Measures

Primary Outcomes (1)

  • Time spent in therapeutic range of INR by the patients

    6 months

Secondary Outcomes (1)

  • Thrombotic and bleeding events

    6 months

Study Arms (1)

Patients in oral anticoagulant therapy

Patients taking oral anticoagulant therapy

Eligibility Criteria

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

the conditions for the patients inclusion are: to take oral anticoagulant therapy for at least 2 years; to be in stable conditions for at last 3 months

You may qualify if:

  • to take oral anticoagulant therapy for at least 2 years
  • to be in stable conditions for at last 3 months

You may not qualify if:

  • patients who need to perform surgery
  • patients who interrupt therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Macerata

Macerata, Macerata, 62100, Italy

Location

Study Officials

  • Michela Basileo, Dr

    University Of Perugia

    PRINCIPAL INVESTIGATOR

  • Alfonso Iorio, Dr

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dt

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

November 1, 2010

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

IT(1)