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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Platelet Aggregation

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).

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Accriva Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Accriva Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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]

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Accriva Diagnostics
• Investigators: Study Chair: Marc Rubinstein, MD, Instrumentation Laboratory; Study Director: Michael Martin, Accrira Diagnostics / Instrumentation Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Platelet Aggregation; P2Y12 Inhibitor
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: VFN-CSS-19-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No