VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study

Completed

• Conditions: Coronary Disease; Platelet Aggregation

• Registration Number: NCT04492423
• Lead Sponsor: Accriva Diagnostics

Brief Summary

The purpose of this study is to determine the range of expected PRUTest values in patients in the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel (Effient®), or ticagrelor (Brilinta®).

Detailed Description

The on-drug reference range study will be performed by measuring venous blood samples in duplicate collected from patients receiving prasugrel (Effient®), or ticagrelor (Brilinta®). Subjects must be on aspirin at the doses prescribed by their treating physician.

When possible, venous blood samples may be collected in conjunction with routine laboratory testing, to minimize the number of needle sticks for the subject. Alternatively, samples may be collected separately to complete the study.

A CBC measurement must be performed for each enrolled subject from a sample collected at the time of blood draw or within ± one week and tested at a certified laboratory. Samples for PRUTest collected in conjunction with a CBC must be drawn after the PRUTest sample.

Up to 130 subjects will be enrolled in the study to facilitate collection of the minimum number of blood samples needed to determine the on-drug reference range of prasugrel (Effient®), or ticagrelor (Brilinta®).

Study Timeline

• Study Start: 2016-09-06
• Primary Completion: 2017-08-14
• Study Completion: 2018-03-22
• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• • Males and females 18 years and older

  • Able and willing to provide written informed consent.
  • Current treatment with aspirin (any dose).
  • Have a planned or scheduled percutaneous coronary intervention (PCI) with the potential to receive treatment with prasugrel (Effient®), or ticagrelor (Brilinta®) following an oral loading dose or on maintenance treatment for a minimum of seven days who may have symptomatic cerebrovascular disease (transient ischemic attack or following a thrombotic stroke) or cardiovascular disease.

Exclusion Criteria

• • Unable to provide written informed consent.

  • Currently receiving an investigational antiplatelet agent.
  • GP IIb/IIIa therapy (ReoPro®, Integrilin®, Aggrastat®) within the past 2 weeks.
  • Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the past 2 weeks.
  • Women who may be pregnant or are of child bearing potential

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRUTest	Within 24 hours of the loading or last maintance dose	VerifyNow PRUTest results