Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigati… (NCT03615846) | Clinical Trial Compass
UnknownNot Applicable
Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
United States147 participantsStarted 2021-02-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 \[e.g. ticagrelor, prasugrel\]