T-TAS® WS Method Comparison

Last updated: March 7, 2025
Sponsor: Hikari Dx, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Healthy Volunteers

Treatment

T-TAS PL Assay

Clinical Study ID

NCT06710262
NX-VAP-AP-I0001
  • Ages > 21
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Ostensibly Healthy Donors

Inclusion Criteria:

  • Males and females age 21 years or older.

  • Able and willing to provide written informed consent.

Exclusion

Exclusion Criteria:

  • Hospitalization or doctor's visits within prior 30 days, except for routinecheckup/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 suchas naproxen or ibuprofen within the past 3 days, unless confirmed to not inhibitplatelet 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'sthrombasthenia or Bernard-Soulier syndrome.

  • History of hemophilia or bleeding disorders.

  • Known active gastrointestinal disease including peptic ulcers, gastro-esophagealreflux disease (GERD), and hyperacidity.

  • Currently participating in a study involving an investigational drug or compoundknown to affect coagulation or hemostasis.

  • Subjects with significant past medical history as determined by the Investigatorthat 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 theprior 5 days followed by 75 mg daily clopidogrel, or 2) 75 mg daily clopidogreldaily 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 dailyprasugrel daily for ≥5 days.

  • 81 mg aspirin plus either 1) 180 mg ticagrelor loading dose within the prior 5 daysfollowed by 2x90 mg daily ticagrelor, or 2) 2x90 mg daily ticagrelor daily for ≥5days.

  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Use of antiplatelet therapy other than aspirin, clopidogrel, prasugrel, orticagrelor (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, Glanzmannthrombasthenia 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-esophagealreflux disease (GERD), and hyperacidity.

  • Currently participating in a study involving an investigational drug or compoundknown to affect coagulation or hemostasis.

  • Subjects with significant past medical history as determined by the Investigatorthat 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 suchas naproxen or ibuprofen within the past 7 days, unless confirmed to not inhibitplatelet 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 compoundknown to affect coagulation or hemostasis.

  • Subjects with significant past medical history as determined by the Investigatorthat would pose safety concerns or interfere with the study goals.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: T-TAS PL Assay
Phase:
Study Start date:
August 21, 2024
Estimated Completion Date:
March 31, 2025

Study 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)

Connect with a study center

  • University of Florida Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

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