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

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®).

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Platelet Aggregation
• Intervention / Treatment: Diagnostic test: VerifyNow PRUTest

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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®).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prasugrel; Patients taking prasugrel	Diagnostic test: VerifyNow PRUTest; VerifyNow PRUTest for platelet aggregation
Ticagrelor; Patients taking ticagrelor	Diagnostic test: VerifyNow PRUTest; VerifyNow PRUTest for platelet aggregation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRUTest	VerifyNow PRUTest results	Within 24 hours of the loading or last maintance dose

Collaborators and Investigators

• Sponsor: Accriva Diagnostics
• Investigators: Principal Investigator: Dominick J Angiolillo, M.D., Ph.D., Uunversity of Florida Health Jacksonville

Publications and helpful links

General Publications

• Angiolillo DJ, Been L, Rubinstein M, Martin M, Rollini F, Franchi F. Use of the VerifyNow point of care assay to assess the pharmacodynamic effects of loading and maintenance dose regimens of prasugrel and ticagrelor. J Thromb Thrombolysis. 2021 Apr;51(3):741-747. doi: 10.1007/s11239-021-02386-7. Epub 2021 Feb 13.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2016
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Aspirin; platelet; aggregation; P2Y12 inhibitor
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: VFN-CSS-16-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Publication of Results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes