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
|Condition or disease|
|Platelet Refractoriness Platelet Aggregation|
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.
|Study Type :||Observational|
|Estimated Enrollment :||210 participants|
|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|
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.
- VerifyNow® PRUTest [ Time Frame: 1 day ]Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow PRUTest
- VerifyNow® Aspirin Test [ Time Frame: 1 day ]Correlation of AggRAM Light Transmittance Aggregometry (LTA) compared to VerifyNow Aspirin Test
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
|Contact: Michael Martinemail@example.com|
|Contact: Cathy Smithfirstname.lastname@example.org|
|United States, Maryland|
|Accriva Study Site|
|Baltimore, Maryland, United States, 21215|
|United States, New York|
|Accriva Study Site|
|New York, New York, United States, 10016|
|United States, Tennessee|
|Accriva Study Site|
|Memphis, Tennessee, United States, 38112|
|Study Chair:||Marc Rubinstein, MD||Instrumentation Laboratory|
|Study Director:||Michael Martin||Accrira Diagnostics / Instrumentation Laboratory|