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

Anticoagulated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392040
• Other study ID #: MIV_AI_10_001
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: January 16, 2013
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anticoagulated Patients

Locations

Country	Name	City	State
Italy	Hospital of Macerata	Macerata

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent in therapeutic range of INR by the patients		6 months	Yes
Secondary	Thrombotic and bleeding events		6 months	Yes