Coronary DiseaseNCT04492423
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
An observational study of Coronary Disease and Platelet Aggregation, run by Accriva Diagnostics.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Platelet Aggregation
- What is being tested?
- VerifyNow PRUTest
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2016to 22 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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®).
Who may be able to join
- • 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.
Who cannot join
- • 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
About this study
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®).
Read the 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 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
- Coronary Disease, Platelet Aggregation
- Being tested
- VerifyNow PRUTest
- Keywords
- aggregation, platelet, P2Y12 inhibitor, Aspirin
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerifyNow PRUTestDiagnostic test
VerifyNow PRUTest for platelet aggregation
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Patients taking prasugrel Receives: Diagnostic Test: VerifyNow PRUTest | |
| Ticagrelor | Patients taking ticagrelor Receives: Diagnostic Test: VerifyNow PRUTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRUTest
VerifyNow PRUTest results
Measured: Within 24 hours of the loading or last maintance dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start6 Sep 2016
- Primary completion14 Aug 2017
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accriva Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominick J Angiolillo, M.D., Ph.D., Principal investigator, Uunversity of Florida Health Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492423
- Sponsor's protocol ID
- VFN-CSS-16-0003
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Publication of Results
Publications
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.
PubMed 33582955
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
- ClinicalTrials.gov ID
- NCT04492423
- Acronym / sponsor ID
- VFN-CSS-16-0003
- Conditions
- Coronary Disease, Platelet Aggregation
- Keywords
- aggregation, platelet, P2Y12 inhibitor, Aspirin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Accriva DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
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 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®).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | – | Diagnostic Test: VerifyNow PRUTestPatients taking prasugrel |
| Ticagrelor | – | Diagnostic Test: VerifyNow PRUTestPatients taking ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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®).
Key inclusion criteria (4 listed)
- • Males and females 18 years and older
Key exclusion criteria (5 listed)
- • Unable to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerifyNow PRUTestVerifyNow PRUTest for platelet aggregation | Diagnostic test | Prasugrel, Ticagrelor |
Primary outcome
PRUTest
Time frame: Within 24 hours of the loading or last maintance dose
VerifyNow PRUTest results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 33582955Angiolillo 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.
- Individual participant dataSharing planned: No. Publication of Results
Related trials for Coronary Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominick J Angiolillo, M.D., Ph.D. principal investigator
Uunversity of Florida Health Jacksonville
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Platelet Aggregation, run by Accriva Diagnostics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRUTest (time frame: Within 24 hours of the loading or last maintance dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.