Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01392040

Enrollment

100

Registered

2011-07-12

Start date

2010-11-30

Completion date

2013-01-31

Last updated

2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulated Patients

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Time spent in therapeutic range of INR by the patients	6 months

Secondary

Measure	Time frame
Thrombotic and bleeding events	6 months

Countries

Italy

Outcome results