T-TAS® wS Method Comparison

Completed

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

In brief

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

Key facts

Study ID

NCT06710262

Run by

Hikari Dx, Inc.

People needed

115

Starts

2024-08-21

Expected to finish

2025-07-14

Last updated by the study team

2025-07-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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