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OpenTrials
Completed

NCT Number: NCT04702113

Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

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.

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Key information

Conditions

Thrombosis Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Hemorrhage Infarction Ischemia Ischemic Stroke Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stent Thrombosis Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctors Hospital at Renaissance

Edinburg, Texas, 78539, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cipherome Lighthouse Pilot

Diagnostic Test

Preemptive pharmacogenomic testing

Primary outcomes

  1. Evaluation of aggregate costs

    Time frame: 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 outcomes

  1. Reduction of treatment failures

    Time frame: 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)

  2. Reduction of major or minor bleeding events

    Time frame: 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 outcomes

  1. Assessment of the correlation of clinical factors (age, labs, medications) on predicting and preventing adverse drug reactions

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cipherome, Inc.

Industry

Collaborators

  • DHR Health Institute for Research and Development

Registry information

Official study title

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

Acronym: CARES2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2021
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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