Antiplatelet Therapy, Healthy Donors, Von Willebrand Disease (VWD)
Conditions
Keywords
T-TAS, Primary hemostasis
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)
Interventions
DIAGNOSTIC_TESTT-TAS PL Assay
The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function
Sponsors
ZACROS Corporation
Hikari Dx, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Method agreement | 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. | Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems |
Countries
United States
Outcome results
None listed