NCT02139072

Brief Summary

The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 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

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

May 13, 2014

Last Update Submit

October 3, 2016

Conditions

Antiphospholipid Antibody Syndrome

Keywords

AnticoagulationInternational normalized ratioWarfarin

Outcome Measures

Primary Outcomes (1)

  • International Normalized Ratio (INR)

    Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant

    Day 1 and Day 60

Study Arms (2)

CoaguChek XS

INR measured by CoaguChek XS in patients with APL at visit 1 and visit 2, in addition to routine measure by standard lab draw

Device: CoaguChek XSProcedure: Standard Lab Draw

Standard Lab Draw

INR measured by standard lab draw at visit 1 and visit 2 for non-APL patients, in addition to routine measurement by CoaguChek XS

Device: CoaguChek XSProcedure: Standard Lab Draw

Interventions

CoaguChek XSDEVICE

CoaguChek XS will be used to measure INR in patients with APL

CoaguChek XSStandard Lab Draw
Standard Lab DrawPROCEDURE

Patients on warfarin for any indication other than APL will measure INR by venous lab draw

CoaguChek XSStandard Lab Draw

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.

You may qualify if:

  • years of age
  • anticoagulated with warfarin for at least 1 month
  • Diagnosis of antiphospholipid antibody syndrome for intervention arm

You may not qualify if:

  • any type of mental disability that would hinder their ability to give informed consent
  • any terminal illness or any other condition that could interfere with study completion, that person will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF and Shands Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Officials

  • James Taylor, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-01

Locations

US(1)