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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03615846

Enrollment

147

Registered

2018-08-06

Start date

2021-02-15

Completion date

2022-10-30

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Platelet Aggregation

Keywords

Platelet Aggregation, P2Y12 Inhibitor

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \[e.g. ticagrelor, prasugrel\]

Design outcomes

Primary

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

Countries

United States

Outcome results