T-TAS® WS Method Comparison

Hikari Dx

Status: Enrolling

Conditions: Antiplatelet Therapy; Healthy Donors; Von Willebrand Disease (VWD)

Treatments: Diagnostic Test: T-TAS PL Assay

Study type: Observational

Funder types: Other

Identifiers

NCT06710262

NX-VAP-AP-I0001

Details and patient eligibility

About

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

Full 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)

Enrollment: 120 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

120 participants in 4 patient groups

Healthy donors

Description:

Subjects with no evidence of primary hemostasis abnormalities

Treatment:

Diagnostic Test: T-TAS PL Assay

Aspirin monotherapy

Description:

Subjects taking aspirin monotherapy

Treatment:

Diagnostic Test: T-TAS PL Assay

Dual antiplatelet therapy

Description:

Subjects taking dual antiplatelet therapy (aspirin plus either clopidogrel, prasugrel, or ticagrelor)

Treatment:

Diagnostic Test: T-TAS PL Assay

Von Willebrand Disease

Description:

Subjects with a prior diagnosis of Von Willebrand Disease

Treatment:

Diagnostic Test: T-TAS PL Assay