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

NCT03615846 | Unknown

• 1 other identifier: VFN-CSS-19-0008
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 2

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.

Conditions

Platelet Aggregation; Coronary Artery Disease

Keywords

Platelet Aggregation; P2Y12 Inhibitor

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 \[e.g. ticagrelor, prasugrel\]

Sponsors & Collaborators

• Accriva Diagnostics: lead

Study Sites (2)

Accriva Study Site

Jacksonville, Florida, 32209, United States

Location

Accriva Study Site

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marc Rubinstein, MD

  Instrumentation Laboratory

  STUDY CHAIR

• Michael Martin

  Accrira Diagnostics / Instrumentation Laboratory

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 6, 2018
• Study Start: February 15, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)