Clinical trial NCT06710262: T-TAS® WS Method Comparison
Official title: T-TAS® WS Method Comparison
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antiplatelet Therapy
Healthy Donors
Von Willebrand Disease (VWD)
Keywords: T-TAS
Primary hemostasis
Lead sponsor: Hikari Dx, Inc.
Sponsor class: OTHER
Collaborators: name: ZACROS Corporation
First posted: 2024-11-29
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital or clinic patients, healthy volunteers

Brief summary: This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument

Detailed description: This study will compare PL assay measurements obtained with the T-TAS wS instrument (subject device) with PL assay measurements obtained with the T-TAS 01 instrument (predicate method). The T-TAS PL assay will be used to facilitate the comparison between instruments using intended use blood samples from the intended use population. The study will be conducted at a minimum of 3 locations in the United States and will enroll up to 120 subjects. The following subject populations will be enrolled into the study (minimum enrollment numbers indicated in parentheses):

* Ostensibly healthy subjects
* Subjects taking 81 mg or higher daily aspirin monotherapy (ASA)
* Subjects taking dual antiplatelet therapy (DAPT)
* Subjects with von Willebrand disease (VWD)

Eligibility criteria: Ostensibly Healthy Donors

Inclusion Criteria:

* Males and females age 21 years or older.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Hospitalization or doctor's visits within prior 30 days, except for routine checkup/physical examination.
* Use of antiplatelet therapy within the past 7 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
* Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
* Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
* History of anemia.
* Known thrombocytopenia (platelet count \< 100,000/μL).
* Significant renal dysfunction or dialysis.
* History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann's thrombasthenia or Bernard-Soulier syndrome.
* History of hemophilia or bleeding disorders.
* Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
* Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
* Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

Antiplatelet Therapy Subjects

Inclusion Criteria:

* Males and females age 21 years or older.
* One of the following antiplatelet therapy regimens:
* Aspirin monotherapy:
* 81 mg or higher aspirin daily for 1 or more days
* Dual antiplatelet therapy:
* 81 mg or higher aspirin plus either 1) ≥300 mg clopidogrel loading dose within the prior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogrel daily for ≥5 days.
* 81 mg or higher aspirin plus either 1) 60 mg prasugrel loading dose within the prior 5 days followed by either 5 or 10 mg daily prasugrel, or 2) 5 or 10 mg daily prasugrel daily for ≥5 days.
* 81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 days followed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5 days.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, or ticagrelor (e.g. cilostazol, abciximab, eptifibatide) within the past 7 days.
* Use of anticoagulant drugs within the past 7 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
* Significant renal dysfunction or dialysis.
* Known thrombocytopenia (platelet count \< 100,000/μL).
* History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann thrombasthenia or Bernard-Soulier syndrome.
* History of hemophilia or bleeding disorders.
* Females who are in the last trimester of pregnancy or are breastfeeding.
* Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
* Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
* Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

Von Willebrand Disease Subjects

Inclusion Criteria:

* Males and females age 21 years or older.
* Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Prior diagnosis of von Willebrand disease type 2N
* Use of antiplatelet therapy besides aspirin within the past 14 days.
* Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
* Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit COX-1 such as naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibit platelet activity (such as celecoxib).
* Significant renal dysfunction or dialysis.
* Known thrombocytopenia (platelet count \< 100,000/μL).
* Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
* Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

Primary outcomes:
measure: Method agreement
timeFrame: For each enrolled subject, following testing of blood sample with the T-TAS PL assay; data will be compiled and analyzed in aggregate at the time of study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
References: