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

Completed

• Conditions: Anticoagulated Patients

• Registration Number: NCT01392040
• Lead Sponsor: University Of Perugia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2012-08
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time spent in therapeutic range of INR by the patients	6 months

Secondary Outcome Measures

Name	Time	Method
Thrombotic and bleeding events	6 months

Trial Locations

Locations (1)

Hospital of Macerata; 🇮🇹 Macerata, Italy