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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03615846
• Other study ID #: VFN-CSS-19-0008
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2021
• Source: Accriva Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Coronary Artery Disease
• Platelet Aggregation

Locations

Country	Name	City	State
United States	Accriva Study Site	Baltimore	Maryland
United States	Accriva Study Site	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Accriva Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VerifyNow® PRUTest	Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest	1 day
Primary	VerifyNow® Aspirin Test	Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test	1 day
Primary	Naive	Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test and VerifyNow PRUTest	1 day