Antiplatelet TherapyNCT06710262
T-TAS® wS Method Comparison
An observational study of Antiplatelet Therapy and Healthy Donors, run by Hikari Dx, Inc. at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Antiplatelet Therapy, Healthy Donors, Von Willebrand Disease (VWD)
- What is being tested?
- T-TAS PL Assay
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2024to 14 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital or clinic patients, healthy volunteers
Who may be able to join
- Males and females age 21 years or older.
- Able and willing to provide written informed consent.
- 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
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- 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.
- 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.
Who cannot join
- 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).
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- 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
- 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
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
About this study
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
Read the 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)
- Being tested
- T-TAS PL Assay
- Keywords
- T-TAS, Primary hemostasis
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-TAS PL AssayDiagnostic test
The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function
| Study group | Role | What they receive |
|---|---|---|
| Healthy donors | Subjects with no evidence of primary hemostasis abnormalities Receives: Diagnostic Test: T-TAS PL Assay | |
| Aspirin monotherapy | Subjects taking aspirin monotherapy Receives: Diagnostic Test: T-TAS PL Assay | |
| Dual antiplatelet therapy | Subjects taking dual antiplatelet therapy (aspirin plus either clopidogrel, prasugrel, or ticagrelor) Receives: Diagnostic Test: T-TAS PL Assay | |
| Von Willebrand Disease | Subjects with a prior diagnosis of Von Willebrand Disease Receives: Diagnostic Test: T-TAS PL Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method agreement
Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start21 Aug 2024
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikari Dx, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- ZACROS Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710262
- Sponsor's protocol ID
- NX-VAP-AP-I0001
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results may be proprietary and/or used to support regulatory submissions
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-TAS® wS Method Comparison
- ClinicalTrials.gov ID
- NCT06710262
- Acronym / sponsor ID
- NX-VAP-AP-I0001
- Keywords
- T-TAS, Primary hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hikari Dx, Inc.University, hospital or other
- Collaborators
- ZACROS Corporation
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy donors | – | Diagnostic Test: T-TAS PL AssaySubjects with no evidence of primary hemostasis abnormalities |
| Aspirin monotherapy | – | Diagnostic Test: T-TAS PL AssaySubjects taking aspirin monotherapy |
| Dual antiplatelet therapy | – | Diagnostic Test: T-TAS PL AssaySubjects taking dual antiplatelet therapy (aspirin plus either clopidogrel, prasugrel, or ticagrelor) |
| Von Willebrand Disease | – | Diagnostic Test: T-TAS PL AssaySubjects with a prior diagnosis of Von Willebrand Disease |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital or clinic patients, healthy volunteers
Key inclusion criteria (14 listed)
- Males and females age 21 years or older.
- Able and willing to provide written informed consent.
- Males and females age 21 years or older.
- One of the following antiplatelet therapy regimens:
- Aspirin monotherapy:
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-TAS PL AssayThe T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function | Diagnostic test | Aspirin monotherapy, Dual antiplatelet therapy, Healthy donors, Von Willebrand Disease |
Primary outcome
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.
Agreement of PL assay AUC results between the T-TAS wS and T-TAS 01 measurement systems
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No. Results may be proprietary and/or used to support regulatory submissions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiplatelet Therapy and Healthy Donors, run by Hikari Dx, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.