Bleeding, Ischemic Stroke, Myocardial Infarction, Stent Thrombosis, Thrombosis
Conditions
Keywords
Stent Thrombosis, Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTCipherome Lighthouse Pilot
Preemptive pharmacogenomic testing
Sponsors
DHR Health Institute for Research and Development
Cipherome, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open label study.
Intervention model description
There will be two study arms: 1. Conventional therapy (controls)-treatment with clopidogrel and no pre-emptive genotyping 2. Genotype-guided therapy (experimental)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of aggregate costs | Study pilot duration is 365 days (1 year) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of treatment failures | Study pilot duration is 365 days (1 year) | Reduced treatment failures within 30, 60, 90 days, and 12 months of receiving clopidogrel in participants with reduced function alleles (CYP2C19 \*2 or \*3) |
| Reduction of major or minor bleeding events | Study pilot duration is 365 days (1 year) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the correlation of clinical factors (age, labs, medications) on predicting and preventing adverse drug reactions | Study pilot duration is 365 days (1 year) | Assess the correlation of clinical factors (age, liver function tests, concomitant medications, etc.) on predicting and preventing adverse drug reactions (ADRs). |
Countries
United States
Outcome results
None listed