Effect of DrugPhase 4NCT06100510
PFA 100 Evaluation and Reference Interval HOACNY
A Phase 4 study testing Aspirin 325mg in people with Effect of Drug, run by Hematology Oncology Associates of Central New York at 1 site in United States.
Trial summary
The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Aspirin 325mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 10 Oct 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to consent to study
Who cannot join
- Primary hemostasis diagnosis
- Von Willebrand Disease
- Bernard-Soulier syndrome
- Glanzmann thrombasthenia
- Idiopathic thrombocytopenic purpura
- Drug-induced thrombocytopenia
Show all 27Show fewer
- Heparin-induced thrombocytopenia
- Thrombotic thrombocytopenic purpura
- Hemolytic uremic syndrome
- Participant is on anticoagulant therapy
- Specifically thienopyrdines [Ticlopidine, Clopidogrel] and GPIIb/IIIa inhibitors [ReoPro, Aggrastat, Integrilin]
- Participant is on medication that contains ASA or aspirin (see list below in Study Procedure)
- Participant is on nonsteroidal anti-inflammatory agents that are known to induce temporary platelet dysfunction (see list below in Study Procedure)
- Participant is on non-prescription medications containing aspirin (see list below in Study Procedure)
- PFA-100 result falls outside of reference interval listed in the package insert (suggested criteria in the PFA-100 Evaluation Protocol as described in the PFA-100 System: Getting Started Guide)
- If hematocrit is less than 35%
- If platelets are less than 150 x10^3/uL
- Potential for adverse reactions between current medication and aspirin as dictated by staff pharmacist
- Allergy to ASA or aspirin
- Previous allergic reaction to ASA or aspirin
- Participant is pregnant
- Asthma, or history of, with nasal polyps and rhinitis
- Stomach ulcers or bleeding
- Severe kidney disease
- Severe liver disease
- Hemophilia
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
About this study
The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.
- Conditions
- Effect of Drug
- Being tested
- Aspirin 325mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 325mgDrug
Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (non-intervention) Arm | No intervention | Participants who will have PFA 100 testing performed without the ingestion of aspirin. |
| Aspirin Arm | Active comparator | Participants who will have PFA 100 testing performed after the ingestion of aspirin. Receives: Drug: Aspirin 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrument Evaluation Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges]
This portion of the study is to ensure that the functionality of the instrumentation is working properly.
For each participant, their pre-aspirin dose closure times will be compared to their post-aspirin dose closure times.
The typical pattern seen in subjects with normal platelet function (pre-aspirin testing) is closure time (CT) results within the reference range for both the COL/EPI and COL/ADP cartridges (normal).
In general, the pattern seen after aspirin ingestion is a CT result outside the reference range (abnormal) with COL/EPI and within the reference range for COL/ADP (normal).
Measured: 3 months
Reference Interval Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges]
For each participant in the non-intervention/placebo arm, platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges will be captured.
Following guidelines as stated per CLSI document EP28-A3c, a reference interval will be developed from this captured data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start19 Feb 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hematology Oncology Associates of Central New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa O'Sullivan, BS,MLT(ASCP), Principal investigator, EmployeeSteven Duffy, MD, Study director, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100510
- Sponsor's protocol ID
- HOACNYPFA100.001
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFA 100 Evaluation and Reference Interval HOACNY
- ClinicalTrials.gov ID
- NCT06100510
- Acronym / sponsor ID
- HOACNYPFA100.001
- Conditions
- Effect of Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hematology Oncology Associates of Central New YorkUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (non-intervention) Arm | No intervention | –Participants who will have PFA 100 testing performed without the ingestion of aspirin. |
| Aspirin Arm | Active comparator | Drug: Aspirin 325mgParticipants who will have PFA 100 testing performed after the ingestion of aspirin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Able to consent to study
Key exclusion criteria (27 listed)
- Primary hemostasis diagnosis
- Participant is on anticoagulant therapy
- Participant is on medication that contains ASA or aspirin (see list below in Study Procedure)
- Participant is on nonsteroidal anti-inflammatory agents that are known to induce temporary platelet dysfunction (see list below in Study Procedure)
- Participant is on non-prescription medications containing aspirin (see list below in Study Procedure)
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 |
|---|---|---|
| Aspirin 325mgCohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw. | Drug | Aspirin Arm |
Primary outcome
Instrument Evaluation Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges]
Time frame: 3 months
This portion of the study is to ensure that the functionality of the instrumentation is working properly. For each participant, their pre-aspirin dose closure times will be compared to their post-aspirin dose closure times. The typical pattern seen in subjects with normal platelet function (pre-aspirin testing) is closure time (CT) results within the reference range for both the COL/EPI and COL/ADP cartridges (normal). In general, the pattern seen after aspirin ingestion is a CT result outside the reference range (abnormal) with COL/EPI and within the reference range for COL/ADP (normal).
Reference Interval Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges]
Time frame: 3 months
For each participant in the non-intervention/placebo arm, platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges will be captured. Following guidelines as stated per CLSI document EP28-A3c, a reference interval will be developed from this captured data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Theresa O'Sullivan, BS,MLT(ASCP) principal investigator
Employee
Steven Duffy, MD study director
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin 325mg in people with Effect of Drug, run by Hematology Oncology Associates of Central New York at 1 site 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 2 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Instrument Evaluation Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges] (time frame: 3 months). The study lists 2 primary outcomes in all. 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 3 Oct 2024.