Clinical trial NCT04702113: Evaluating Pharmacogenomic Variants for Cardiology Therapeutics
Official title: Evaluating Pharmacogenomic Variants for Cardiology Therapeutics: the Lighthouse Pilot (Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Stent Thrombosis
Bleeding
Myocardial Infarction
Ischemic Stroke
Keywords: Stent Thrombosis
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Lead sponsor: Cipherome, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DHR Health Institute for Research and Development
First posted: 2021-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of aggregate costs
timeFrame: Study pilot duration is 365 days (1 year)
Secondary outcomes:
measure: Reduction of treatment failures
timeFrame: Study pilot duration is 365 days (1 year)
measure: Reduction of major or minor bleeding events
timeFrame: Study pilot duration is 365 days (1 year)
Other outcomes:
measure: Assessment of the correlation of clinical factors (age, labs, medications) on predicting and preventing adverse drug reactions
timeFrame: Study pilot duration is 365 days (1 year)
Locations:
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance
state: Texas
Study officials:
affiliation: DHR Health
name: Herschl Silberman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DHR Health
name: Humberto Mochizu Kitamayo, MD
role: STUDY_DIRECTOR
affiliation: DHR Health
name: Yetunde O Kare Opaneye, MD
role: STUDY_DIRECTOR
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