Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan

NCT ID: NCT03615846

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-10-30

Brief 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.

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),

o 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.
• 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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accriva Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Rubinstein, MD

Role: STUDY_CHAIR

Instrumentation Laboratory

Michael Martin

Role: STUDY_DIRECTOR

Accrira Diagnostics / Instrumentation Laboratory

Locations

Accriva Study Site

Jacksonville, Florida, United States

Accriva Study Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

VFN-CSS-19-0008

Identifier Type: -

Identifier Source: org_study_id