Clinical trial NCT07012291: Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
Official title: Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coagulation
Lead sponsor: Perosphere Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on rivaroxaban or apixaban between the ages of 18 and 80 years old.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.
timeFrame: Day 1
Secondary outcomes:
measure: To characterize performance of the ClotChek™ device via whole blood clotting time measurement within clinically relevant patient subgroups (eg renal or hepatic impairment).
timeFrame: Day 1
Other outcomes:
Locations:
city: Danbury
country: United States
facility: Perosphere Technologies Inc
state: Connecticut
city: Rockville
country: United States
facility: Perosphere Technologies Inc
state: Maryland
city: Denville
country: United States
facility: Eastern Vascular Associates
state: New Jersey
city: Cooperstown
country: United States
facility: Bassett Research Institute - Center for Clinical Research
state: New York
Study officials:
References: