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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-06

Study Completion Date

2018-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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®).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan

NCT03615846

Platelet Aggregation Coronary Artery Disease

UNKNOWN

Replication of the ISAR-REACT 5 Antiplatelet Trial in Healthcare Claims Data

NCT05086081

Acute Coronary Syndrome

COMPLETED

Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery

NCT02291419

Myocardial Injury

TERMINATED PHASE4

Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of ACS

NCT03881943

Acute Coronary Syndrome

COMPLETED PHASE4

Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor

NCT02545933

Myocardial Infarction

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease Platelet Aggregation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prasugrel

Patients taking prasugrel

VerifyNow PRUTest

Intervention Type DIAGNOSTIC_TEST

VerifyNow PRUTest for platelet aggregation

Ticagrelor

Patients taking ticagrelor

VerifyNow PRUTest

Intervention Type DIAGNOSTIC_TEST

VerifyNow PRUTest for platelet aggregation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VerifyNow PRUTest

VerifyNow PRUTest for platelet aggregation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No