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

NCT04492423 | Completed FDA Device

• 1 other identifier: VFN-CSS-16-0003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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®).

Conditions

Coronary Disease; Platelet Aggregation

Keywords

aggregation; platelet; P2Y12 inhibitor; Aspirin

Outcome Measures

Primary Outcomes (1)

• PRUTest

  VerifyNow PRUTest results

  Within 24 hours of the loading or last maintance dose

Study Arms (2)

Prasugrel

Patients taking prasugrel

Diagnostic Test: VerifyNow PRUTest

Ticagrelor

Patients taking ticagrelor

Diagnostic Test: VerifyNow PRUTest

Interventions

VerifyNow PRUTest DIAGNOSTIC_TEST

VerifyNow PRUTest for platelet aggregation

Prasugrel; Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Accriva Diagnostics: lead

Related Publications (1)

• 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.

  PMID: 33582955 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dominick J Angiolillo, M.D., Ph.D.

  Uunversity of Florida Health Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: September 6, 2016
• Primary Completion: August 14, 2017
• Study Completion: March 22, 2018
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share