NCT04492423

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Accriva Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®).

Conditions

• Coronary Disease
• Platelet Aggregation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VerifyNow PRUTest	VerifyNow PRUTest for platelet aggregation

Timeline

• Start date: 2016-09-06
• Primary completion: 2017-08-14
• Completion: 2018-03-22
• First posted: 2020-07-30
• Last updated: 2020-07-30

Regulatory

• FDA-regulated device study