Antiphospholipid Antibody SyndromeNCT02139072
CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients
An observational study of Antiphospholipid Antibody Syndrome, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antiphospholipid Antibody Syndrome
- What is being tested?
- CoaguChek XS and Standard Lab Draw
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
Who may be able to join
- 18-65 years of age
- anticoagulated with warfarin for at least 1 month
- Diagnosis of antiphospholipid antibody syndrome for intervention arm
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome
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.
Read the 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.
- Conditions
- Antiphospholipid Antibody Syndrome
- Being tested
- CoaguChek XS, Standard Lab Draw
- Keywords
- Anticoagulation, International normalized ratio, Warfarin
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoaguChek XSDevice
CoaguChek XS will be used to measure INR in patients with APL
Standard Lab DrawProcedure or surgery
Patients on warfarin for any indication other than APL will measure INR by venous lab draw
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CoaguChek XS; Procedure: 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 Receives: Device: CoaguChek XS; Procedure: Standard Lab Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Normalized Ratio (INR)
Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant
Measured: Day 1 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Antibody SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- James Taylor, PharmD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139072
- Sponsor's protocol ID
- IRB201400096
- Status last verified
- Jan 2016
- First submitted
- 13 May 2014
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome
- ClinicalTrials.gov ID
- NCT02139072
- Acronym / sponsor ID
- IRB201400096
- Conditions
- Antiphospholipid Antibody Syndrome
- Keywords
- Anticoagulation, International normalized ratio, Warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoaguChek XS | – | Device: CoaguChek XS, Procedure: Standard Lab DrawINR measured by CoaguChek XS in patients with APL at visit 1 and visit 2, in addition to routine measure by standard lab draw |
| Standard Lab Draw | – | Device: CoaguChek XS, Procedure: Standard Lab DrawINR measured by standard lab draw at visit 1 and visit 2 for non-APL patients, in addition to routine measurement by CoaguChek XS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
Key inclusion criteria (3 listed)
- 18-65 years of age
- anticoagulated with warfarin for at least 1 month
- Diagnosis of antiphospholipid antibody syndrome for intervention arm
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoaguChek XSCoaguChek XS will be used to measure INR in patients with APL | Device | CoaguChek XS, Standard Lab Draw |
| Standard Lab DrawPatients on warfarin for any indication other than APL will measure INR by venous lab draw | Procedure or surgery | CoaguChek XS, Standard Lab Draw |
Primary outcome
International Normalized Ratio (INR)
Time frame: Day 1 and Day 60
Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Taylor, PharmD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Antibody Syndrome, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Normalized Ratio (INR) (time frame: Day 1 and Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.