Clinical trial NCT03615846: Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
Official title: Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Aggregation
Coronary Artery Disease
Keywords: Platelet Aggregation
P2Y12 Inhibitor
Lead sponsor: Accriva Diagnostics
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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 \[e.g. ticagrelor, prasugrel\]

Primary outcomes:
measure: VerifyNow® PRUTest
timeFrame: 1 day
measure: VerifyNow® Aspirin Test
timeFrame: 1 day
measure: Naive
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Accriva Study Site
state: Florida
city: Baltimore
country: United States
facility: Accriva Study Site
state: Maryland
Study officials:
affiliation: Instrumentation Laboratory
name: Marc Rubinstein, MD
role: STUDY_CHAIR
affiliation: Accrira Diagnostics / Instrumentation Laboratory
name: Michael Martin
role: STUDY_DIRECTOR
References: