Evaluating Pharmacogenomic Variants for Cardiology Therapeutics (CARES2)

September 27, 2023 updated by: Cipherome, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Edinburg, Texas, United States, 78539
        • Doctors Hospital at Renaissance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Study pilot duration is 365 days (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Study pilot duration is 365 days (1 year)
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)
Study pilot duration is 365 days (1 year)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Study pilot duration is 365 days (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cipherome, Inc.

Collaborators

DHR Health Institute for Research and Development

Investigators

  • Principal Investigator: Herschl Silberman, MD, DHR Health
  • Study Director: Humberto Mochizu Kitamayo, MD, DHR Health
  • Study Director: Yetunde O Kare Opaneye, MD, DHR Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Actual)

July 26, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C03-002 DHR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Cipherome Lighthouse Pilot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe