NCT03615846

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Accriva Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Platelet Aggregation
• Coronary Artery Disease

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-10-30
• Completion: 2022-10-30
• First posted: 2018-08-06
• Last updated: 2021-09-14

Locations

2 sites across 1 country: United States