Platelet AggregationNCT03615846
Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
An observational study of Platelet Aggregation and Coronary Artery Disease, run by Accriva Diagnostics at 2 sites in United States.
Trial summary
This is a multi-center convenience sample prospective study comparing the results of the Verify Now® Aspirin Test and PRUTest® Platelet Reactivity Tests with the Japan investigational reagents to reagents registered in Japan in the expected population receiving aspirin (ASA) and the P2Y12 inhibitor clopidogrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Aggregation, Coronary Artery Disease
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2021to 30 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population to be studied consists of subjects who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or Clopidogrel alone for a minimum of 4 weeks, or subjects receiving no drugs with anti-platelet effect.
Who may be able to join
- Males and females 18 years of age or older.
- Subjects regularly taking ASA and clopidogrel, for a minimum of 4 days prior to enrollment, or subjects taking no platelet inhibitors including ASA.
- Willing to participate and able to understand the study, including their rights and any risks associated with their participation, and sign an informed consent.
- Able and willing to donate a blood sample of 15mL.
- Exclusion Criteria
- Enrolled in any other study that involves an investigational drug and/or device.
Show all 16Show fewer
- Smoked within one hour before blood draw.
- Had caffeine within 2 hours before blood draw.
- Had meals with high fat content within 8 hours before blood draw.
- A platelet count below 92,000/µL, or above 502,000/µL for VerifyNow Aspirin Test.*
- A platelet count below 119,000/µL, or above 502,00/µL for VerifyNow PRUTest.*
- A hematocrit level below 29%, or above 56% for VerifyNow Aspirin Test.*
- A hematocrit level below 33%, or above 52% for VerifyNow PRUTest.*
- Within the past 48 hours, exposure to any of the following drugs:
- Antiplatelet/glycoprotein inhibitors [eptifibatide, tirofiban]
- Any antiplatelet drug except clopidogrel and ASA [e.g. ticagrelor, prasugrel]
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Accriva Study Site
Baltimore, Maryland, 21215
Accriva Study Site
Jacksonville, Florida, 32209
About this study
This is a multi-center convenience sample prospective study comparing the results of the Verify Now® Aspirin Test and PRUTest® Platelet Reactivity Tests with the Japan investigational reagents to reagents registered in Japan in the expected population receiving aspirin (ASA) and the P2Y12 inhibitor clopidogrel.
Read the detailed description
- The Primary Objectives of this study are to compare the results of:
- The VerifyNow Aspirin Test with AA, an investigational reagent as defined in Japan, against LTA with AA investigational reagent as defined in Japan (study reference reagent), in subjects receiving DAPT (ASA and clopidogrel or subjects taking no platelet inhibitors including ASA;
- The VerifyNow Aspirin Test with AA, an investigational reagent as defined in Japan, against LTA with collagen (study reference reagent),
- In subjects receiving DAPT (ASA and clopidogrel) or in subjects taking no platelet inhibitors including ASA
- The VerifyNow PRUTest with ADP, an investigational reagent as defined in Japan, and PGE1, against LTA with ADP, an approved reagent in Japan (study reference reagent) and PGE1, and
- The VerifyNow PRUTest with ADP (an investigational reagent as defined in Japan) and PGE1 against LTA with ADP reagent approved in Japan (study reference reagent) with no PGE1, o in up to 75 subjects receiving DAPT (ASA and clopidogrel) and in up to 55 subjects taking no platelet inhibitors (total up to 130 subjects).
- Conditions
- Platelet Aggregation, Coronary Artery Disease
- Keywords
- Platelet Aggregation, P2Y12 Inhibitor
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dual Anti-Platelet Therapy (DAPT) | Whole blood from patients who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) for a minimum of 4 weeks (on-drug) will be used to conduct antiplatelet reactivity tests using VerifyNow assay and LTA with AggRAM Aggregometer with and without PGE1. There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. | |
| One Anti Platelet Medication Only | Whole blood from patients who are currently receiving either ASA or Clopidogrel alone for a minimum of 4 weeks (on-drug) will be used to conduct antiplatelet reactivity tests using VerifyNow assay and LTA with AggRAM Aggregometer with and without PGE1. There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. | |
| naive | No medication with anti-platelet effects There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VerifyNow® PRUTest
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest
Measured: 1 day
VerifyNow® Aspirin Test
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test
Measured: 1 day
Naive
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test and VerifyNow PRUTest
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Feb 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet AggregationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accriva Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Rubinstein, MD, Study chair, Instrumentation LaboratoryMichael Martin, Study director, Accrira Diagnostics / Instrumentation Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615846
- Sponsor's protocol ID
- VFN-CSS-19-0008
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
- ClinicalTrials.gov ID
- NCT03615846
- Acronym / sponsor ID
- VFN-CSS-19-0008
- Conditions
- Platelet Aggregation, Coronary Artery Disease
- Keywords
- Platelet Aggregation, P2Y12 Inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Accriva DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 6 Aug 2018 (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 is a multi-center convenience sample prospective study comparing the results of the Verify Now® Aspirin Test and PRUTest® Platelet Reactivity Tests with the Japan investigational reagents to reagents registered in Japan in the expected population receiving aspirin (ASA) and the P2Y12 inhibitor clopidogrel.
Detailed description
- The Primary Objectives of this study are to compare the results of:
- The VerifyNow Aspirin Test with AA, an investigational reagent as defined in Japan, against LTA with AA investigational reagent as defined in Japan (study reference reagent), in subjects receiving DAPT (ASA and clopidogrel or subjects taking no platelet inhibitors including ASA;
- The VerifyNow Aspirin Test with AA, an investigational reagent as defined in Japan, against LTA with collagen (study reference reagent),
- In subjects receiving DAPT (ASA and clopidogrel) or in subjects taking no platelet inhibitors including ASA
- The VerifyNow PRUTest with ADP, an investigational reagent as defined in Japan, and PGE1, against LTA with ADP, an approved reagent in Japan (study reference reagent) and PGE1, and
- The VerifyNow PRUTest with ADP (an investigational reagent as defined in Japan) and PGE1 against LTA with ADP reagent approved in Japan (study reference reagent) with no PGE1, o in up to 75 subjects receiving DAPT (ASA and clopidogrel) and in up to 55 subjects taking no platelet inhibitors (total up to 130 subjects).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual Anti-Platelet Therapy (DAPT) | – | –Whole blood from patients who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) for a minimum of 4 weeks (on-drug) will be used to conduct antiplatelet reactivity tests using VerifyNow assay and LTA with AggRAM Aggregometer with and without PGE1. There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. |
| One Anti Platelet Medication Only | – | –Whole blood from patients who are currently receiving either ASA or Clopidogrel alone for a minimum of 4 weeks (on-drug) will be used to conduct antiplatelet reactivity tests using VerifyNow assay and LTA with AggRAM Aggregometer with and without PGE1. There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. |
| naive | – | –No medication with anti-platelet effects There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied consists of subjects who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or Clopidogrel alone for a minimum of 4 weeks, or subjects receiving no drugs with anti-platelet effect.
Key inclusion criteria (16 listed)
- Males and females 18 years of age or older.
- Subjects regularly taking ASA and clopidogrel, for a minimum of 4 days prior to enrollment, or subjects taking no platelet inhibitors including ASA.
- Willing to participate and able to understand the study, including their rights and any risks associated with their participation, and sign an informed consent.
- Able and willing to donate a blood sample of 15mL.
- Enrolled in any other study that involves an investigational drug and/or device.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VerifyNow® PRUTest
Time frame: 1 day
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest
VerifyNow® Aspirin Test
Time frame: 1 day
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test
Naive
Time frame: 1 day
Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test and VerifyNow PRUTest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Cookies for Platelets
Blood Donation
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.
Marc Rubinstein, MD study chair
Instrumentation Laboratory
Michael Martin study director
Accrira Diagnostics / Instrumentation Laboratory
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 Platelet Aggregation and Coronary Artery Disease, run by Accriva Diagnostics 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 16 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Sep 2021. 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?
Results are not available in the source record.
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?
VerifyNow® PRUTest (time frame: 1 day). The study lists 3 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 14 Sep 2021.