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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492423
• Other study ID #: VFN-CSS-16-0003
• Status: Completed
• Start date: September 6, 2016
• Est. completion date: March 22, 2018

Study information

• Verified date: July 2020
• Source: Accriva Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®).

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 22, 2018
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease
• Platelet Aggregation

Intervention

Diagnostic Test:
• VerifyNow PRUTest
VerifyNow PRUTest for platelet aggregation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Accriva Diagnostics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRUTest	VerifyNow PRUTest results	Within 24 hours of the loading or last maintance dose