Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

Study Overview
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Brief Summary
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Cipherome's Lighthouse is a clinical decision support tool that incorporates a patient's pharmacogenetic information to determine therapeutic strategy, including determining appropriate dosage or assessing the likelihood of toxicity of a therapeutic regimen.

Detailed Description
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The Lighthouse tool incorporates pharmacogenetic (PGx) variants from well-established, evidence-based guidelines to provide personalized drug response profile(s) to guide treatment decisions. The patient specimen is genotyped using a proprietary, carefully curated pharmacogenetic variant panel to determine the individual's phenotype. The Lighthouse report (PGx findings) are provided to the clinician, and a notification is generated when the patient has a genotype with a deleterious drug-metabolizing phenotype. Evaluating the South Texas community for the pilot project will enhance the understanding of the impact of genetic variants on individuals of Hispanic/Latino ancestry, especially as the variants pertain to the efficacy and safety of medications.

Official Title
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Evaluating Pharmacogenomic Variants for Cardiology Therapeutics: the Lighthouse Pilot (Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects)

Conditions
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Thrombosis, Stent Thrombosis, Bleeding, Myocardial Infarction, Ischemic Stroke

Intervention / Treatment
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* Diagnostic Test: Cipherome Lighthouse Pilot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over 18 years of age, who are: On clopidogrel, prasugrel or ticagrelor after percutaneous stent Completed informed consent Exclusion Criteria: Failure to provide informed consent. Lost to follow-up prior to 60 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two study arms: Conventional therapy (controls)-treatment with clopidogrel and no pre-emptive genotyping Genotype-guided therapy (experimental)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Therapy (Controls)<br>Treatment with clopidogrel and no pre-emptive genotyping | |
| Experimental: Genotype-guided therapy (experimental)<br>Treatment with clopidogrel 75 mg daily for non-carriers Treatment with ticagrelor 90 mg twice daily for carriers | Diagnostic Test: Cipherome Lighthouse Pilot<br>* Preemptive pharmacogenomic testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of aggregate costs | The cumulative direct medical cost (admissions, procedures, clinical visits, blood transfusions, drugs) of percutaneous insertion of stents (PCIs) and associated major adverse cardiovascular and cerebrovascular events (MACCE) including non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality, severe recurrent ischemia and stent thrombosis, and the costs of P2Y12 inhibitors and pharmacogenomic test costs. | Study pilot duration is 365 days (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of treatment failures | Reduced treatment failures within 30, 60, 90 days, and 12 months of receiving clopidogrel in participants with reduced function alleles (CYP2C19 *2 or *3) | Study pilot duration is 365 days (1 year) | 
| Reduction of major or minor bleeding events | Reduced major or minor bleeding events within 30, 60, 90 days, and 12 months of receiving clopidogrel in participants with increased function alleles (CYP2C19 *17) | Study pilot duration is 365 days (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent Thrombosis, Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)