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VerifyNow® Aspirin Test and PRUTest Platelet Reactivity Compared to the AggRAM Aggregometer

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ClinicalTrials.gov Identifier: NCT03615846
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Accriva Diagnostics

Brief Summary:
This study is designed to compare the approved VerifyNow PRUTest and the VerifyNow Aspirin Test results against the approved comparator / reference instrument AggRAM Aggregometer (450μl cuvette only), with and without the PGE1 reagent (agonist) in patients receiving either dual antiplatelet therapy (DAPT) with aspirin (ASA) and Clopidogrel, or in patients receiving either ASA or Clopidogrel. The secondary objective of this study is to demonstrate the capability of both assays to discern between normal and abnormal (on P2Y12 inhibitors or ASA) sample response. This is a multi-center, prospective method comparison, with data to be analyzed separately from each site as well as combined for all sites.

Condition or disease
Platelet Refractoriness Platelet Aggregation

Detailed Description:

The study will be performed in the clinical setting by trained professional operators.

Group 1: Platelet Activation Test 1, VerifyNow PRUTest and VerifyNow Aspirin Test Group 2: Platelet Activation Test 2, AggRAM Aggregometer with and without the PGE1 reagent Ex-vivo whole blood samples will be used from study patients who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or Clopidogrel alone for a minimum of 4 weeks (on-drug) to test antiplatelet reactivity.

This study will enroll up to 170 including male and female patients aged 18 years or older who have been on P2Y12 inhibitor (clopidogrel) and ASA Dual Antiplatelet Therapy for a minimum of 4 weeks. Patients will be recruited over an approximate 2-month period from the population of the study site(s). Because of the variability of biologic response to ASA and P2Y12 inhibitor class of medications (and therefore platelet inhibition), patients may contribute up to two samples for this study, provided that these samples are collected at least 2 weeks apart.

After collection of 130 samples from on drug patients, there will be an interim enrollment (only) pause and review to determine the number of DAPT non responders who were non-responders to either Clopidogrel or ASA, and then to open enrollment to patients prescribed Clopidogrel or ASA only in order to complete the missing ASA or Clopidogrel data from negative assay results. No interim analysis of the data will be performed.

The workflow for the antiplatelet reactivity testing process will be consistent across all sites. Expected duration of the study is dependent upon the site logistics but generally is expected to last no more than two months.

Results generated during this study will be used solely for research purposes and will not be used for antiplatelet management of study subjects. No patient follow up is required.

The study will include two VerifyNow System for PRUTest and Aspirin Test and AggRAM Aggregometer, and trained professional operators.

All study data will be collected on Case Report Forms and all analysis will be performed by Accriva.


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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Equivalency of VerifyNow® Aspirin Test and PRUTest Platelet Reactivity Results Compared to Results From the AggRAM Aggregometer With and Without PGE1
Estimated Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort
All Patients

Whole blood from patients who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or Clopidogrel alone for a minimum of 4 weeks (on-drug) will be used to conduct antiplatelet reactivity tests using VerifyNow assay and LTA with AggRAM Aggregometer with and without PGE1.

There is no drug administration or therapeutic intervention in this study. The results of platelet activation testing using VerifyNow performed in this study are not used to influence patient care.




Primary Outcome Measures :
  1. VerifyNow® PRUTest [ Time Frame: 1 day ]
    Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest

  2. VerifyNow® Aspirin Test [ Time Frame: 1 day ]
    Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population to be studied consists of subjects who are currently receiving Dual Anti-Platelet Therapy (DAPT) Clopidogrel and aspirin (ASA) or receiving either ASA or Clopidogrel alone for a minimum of 4 weeks
Criteria

Inclusion Criteria:

  • Males and females 18 years or older
  • Willing to participate and able to understand the study, including their rights and any risks associated with their participation, and sign an informed consent
  • Patients prescribed and regularly taking aspirin and clopidogrel (Plavix®) for a minimum of 4 weeks prior to enrollment
  • Able to donate a blood sample of up to 35 mL

Exclusion Criteria:

  • Unable or unwilling to donate the required 35 mL blood sample
  • Enrolled in any other study that involves an investigational drug and/or device
  • Taking any NSAID
  • Platelet count below 90,000/µL (LTA minimum), or above 741,000/µL
  • Hematocrit level below 25%, or above 52%
  • Patients should not be enrolled if taking any other substance that may specifically block the P2Y12 receptor within the previous 14 days, or exposure to abciximab (within 14 days prior) and eptifibatide, or tirofiban (within the last 48 hours)
  • Patients should not be enrolled if taking any of these medications (Average duration times are listed for each drug):

    • Ticlid (up to 5 days)
    • Aggrenox (10 days)
    • Pletal/Cilostazol (12 hours)
    • Ibuprofen (Motrin, Advil) (8 hours)
    • Naproxen (Aleve, Anaprox, Naprelan, Naprosyn) (24 hours)
    • Diclofenac (Voltaren, Cataflam) (24 hours)
    • Indocin (24 hours)
    • Feldene (50 hours)
    • tirofiban (Aggrastat®) within two days
    • eptifibatide (Integrilin®) within two days
    • abciximab (ReoPro®) within two weeks
    • Vorapaxar for 30 days
    • Received any therapy containing dipyridamole (Persantine®, Aggrenox®) within the past 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615846


Contacts
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Contact: Michael Martin 858-263-2300 mmartin@ilww.com
Contact: Cathy Smith 858-263-2300 csmith@ilww.com

Locations
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United States, Maryland
Accriva Study Site Not yet recruiting
Baltimore, Maryland, United States, 21215
United States, New York
Accriva Study Site Not yet recruiting
New York, New York, United States, 10016
United States, Tennessee
Accriva Study Site Not yet recruiting
Memphis, Tennessee, United States, 38112
Sponsors and Collaborators
Accriva Diagnostics
Investigators
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Study Chair: Marc Rubinstein, MD Instrumentation Laboratory
Study Director: Michael Martin Accrira Diagnostics / Instrumentation Laboratory

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Responsible Party: Accriva Diagnostics
ClinicalTrials.gov Identifier: NCT03615846     History of Changes
Other Study ID Numbers: VFN-CSS-18-0004
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics