CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02139072

Enrollment

Registered

2014-05-15

Start date

2015-03-31

Completion date

2016-01-31

Last updated

2016-10-04

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

Conditions

Antiphospholipid Antibody Syndrome

Keywords

Anticoagulation, International normalized ratio, Warfarin

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.

Detailed description

Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.

Interventions

DEVICECoaguChek XS

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

PROCEDUREStandard Lab Draw

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 18-65 years of age * anticoagulated with warfarin for at least 1 month * Diagnosis of antiphospholipid antibody syndrome for intervention arm

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
International Normalized Ratio (INR)	Day 1 and Day 60	Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026