Clinical Validation of a New Algorithm for Computerized D... | NCT01392040

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

NCT01392040

Sponsor

University Of Perugia

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Anticoagulated Patients

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 11, 2011

First Posted Date

Jul 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients in oral anticoagulant therapy		Patients taking oral anticoagulant therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Thrombotic and bleeding events		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michela Basileo, Dr	University Of Perugia	Principal Investigator
Alfonso Iorio, Dr	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of Macerata		Province of Macerata	Macerata	62100	Italy