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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615846
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Accriva Diagnostics

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.

Condition or disease
Platelet Aggregation Coronary Artery Disease

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).

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

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.



Primary Outcome Measures :
  1. VerifyNow® PRUTest [ Time Frame: 1 day ]
    Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest

  2. VerifyNow® Aspirin Test [ Time Frame: 1 day ]
    Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test

  3. Naive [ Time Frame: 1 day ]
    Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test and VerifyNow PRUTest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615846


Contacts
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Contact: Michael Martin 858-263-2300 mmartin@ilww.com
Contact: Cathy Smith 858-263-2300 csmith@ilww.com

Locations
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United States, Florida
Accriva Study Site
Jacksonville, Florida, United States, 32209
United States, Maryland
Accriva Study Site
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Accriva Diagnostics
Investigators
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Study Chair: Marc Rubinstein, MD Instrumentation Laboratory
Study Director: Michael Martin Accrira Diagnostics / Instrumentation Laboratory
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Responsible Party: Accriva Diagnostics
ClinicalTrials.gov Identifier: NCT03615846    
Other Study ID Numbers: VFN-CSS-19-0008
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Accriva Diagnostics:
Platelet Aggregation
P2Y12 Inhibitor
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases