Status:
COMPLETED
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
Lead Sponsor:
Accriva Diagnostics
Conditions:
Coronary Disease
Platelet Aggregation
Eligibility:
All Genders
18+ years
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®), o...
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 o...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
September 6 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 22 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04492423
Start Date
September 6 2016
End Date
March 22 2018
Last Update
July 30 2020
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