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

Recruiting now

Conditions studied: Coagulation

In brief

The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC). The instrument performs a whole blood clotting time (WBCT) test using freshly drawn, non-citrated whole blood. The purpose of the present study is to characterize the performance of the Perosphere ClotChek™ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.

Key facts

Study ID: NCT07012291
Run by: Perosphere Technologies Inc.
People needed: 150
Starts: 2025-06-20
Expected to finish: 2027-06-01
Last updated by the study team: 2025-09-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Perosphere Technologies Inc — Danbury, Connecticut, United States (enrolling)
Perosphere Technologies Inc — Rockville, Maryland, United States (enrolling)
Eastern Vascular Associates — Denville, New Jersey, United States (enrolling)
Bassett Research Institute - Center for Clinical Research — Cooperstown, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.