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Evaluating the Perosphere ClotChek™ Device for Patients on Rivaroxaban or Apixaban

This study is looking at how well a new handheld device, called the Perosphere ClotChek™, measures how quickly your blood clots. This device uses a fresh blood sample to get a "whole blood clotting time" (WBCT). Researchers want to see if this device can accurately tell the difference between people taking the blood thinners rivaroxaban or apixaban, and people who are not on these medications. You may be able to join if you are between 18 and 80 years old, and have been taking rivaroxaban or apixaban regularly for at least one month. The study aims to enroll 150 participants. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will be observing existing conditions. It plans to include 150 participants.
What's involved
You would provide fresh whole blood samples at various times during the day. These samples will be tested using the Perosphere ClotChek™ device.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Day 1.

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NCT07012291

Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™

Recruiting
Not specifiedAges 18–80Observational
Perosphere Technologies Inc.
~150 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Whole Blood Clotting Time

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.
Measured over Day 1

Conditions

Coagulation

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Coagulation

NCT07012291

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Bassett Research Institute - Center for Clinical Research

    Cooperstown, New Yorkstudy coordinator listed

    Recruiting

  • Eastern Vascular Associates

    Denville, New Jerseystudy coordinator listed

    Recruiting

  • Perosphere Technologies Inc

    Danbury, Connecticutstudy coordinator listed

    Recruiting

  • Perosphere Technologies Inc

    Rockville, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Sasha Bakhru, PhD
[email protected]
475-218-4601
Email the study team

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Eligibility criteria

Inclusion

Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
Be 18- to 80-years-of-age, inclusive, at time of consent.
Have suitable venous access for at least a single venipuncture.
Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
Eligible patients on anticoagulants must have been on their anticoagulant therapy for at least one month.

Exclusion

Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions, other than the condition for which a DOAC was prescribed.
Have a history of unexplained syncope.
Have a history within six months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
Consume more than five cigarettes per day.
If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
If female, be pregnant, breastfeeding, or planning to become pregnant during the study.

What this trial measures

  • Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.Day 1