T-TAS® wS Method Comparison

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

Study Overview

• Status: Completed
• Conditions: Healthy Donors; Antiplatelet Therapy; Von Willebrand Disease (VWD)
• Intervention / Treatment: Diagnostic test: T-TAS PL Assay

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)

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospital or clinic patients, healthy volunteers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy donors; Subjects with no evidence of primary hemostasis abnormalities	Diagnostic test: T-TAS PL Assay; The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function
Aspirin monotherapy; Subjects taking aspirin monotherapy	Diagnostic test: T-TAS PL Assay; The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function
Dual antiplatelet therapy; Subjects taking dual antiplatelet therapy (aspirin plus either clopidogrel, prasugrel, or ticagrelor)	Diagnostic test: T-TAS PL Assay; The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function
Von Willebrand Disease; Subjects with a prior diagnosis of Von Willebrand Disease	Diagnostic test: T-TAS PL Assay; The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method agreement	Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems	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.

Collaborators and Investigators

• Sponsor: Hikari Dx, Inc.
• Collaborators: ZACROS Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): July 14, 2025
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Primary hemostasis; T-TAS
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Von Willebrand Diseases
• Other Study ID Numbers: NX-VAP-AP-I0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results may be proprietary and/or used to support regulatory submissions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No