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Not recruiting

T-TAS® WS

Sponsor:

Hikari Dx, Inc.

Code:

NCT06710262

Conditions

Antiplatelet Therapy

Healthy Donors

Von Willebrand Disease (VWD)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

T-TAS PL Assay

Study Details

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

Conditions

Antiplatelet Therapy

Healthy Donors

Von Willebrand Disease (VWD)

Study ID

NCT06710262

Start date

Aug 21, 2024

Status verified date

Mar, 2025

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy donors

Subjects with no evidence of primary hemostasis abnormalities

Aspirin monotherapy

Subjects taking aspirin monotherapy

Dual antiplatelet therapy

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

Von Willebrand Disease

Subjects with a prior diagnosis of Von Willebrand Disease

Interventions

T-TAS PL Assay

The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function

Primary outcome measure

  • Method agreement [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Jeffrey Dahlen, Ph.D.

619-742-0203jeff@hikaridx.com

Locations

University of Florida Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Jeffrey Dahlen, Ph.D.

619-742-0203jeff@hikaridx.com

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Jeffrey Dahlen, Ph.D.

6197420203jeff@hikaridx.com

More Information

Sponsor

Hikari Dx, Inc.

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Keywords

  • T-TAS
  • Primary hemostasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Hikari Dx, Inc. on 2025-03-12.