CARES2: Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

Sponsor
Cipherome, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04702113
Collaborator
DHR Health Institute for Research and Development (Other)
300
2
2
30.8
150
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cipherome Lighthouse Pilot
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There will be two study arms: Conventional therapy (controls)-treatment with clopidogrel and no pre-emptive genotyping Genotype-guided therapy (experimental)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)
Masking Description:
This is an open label study.
Primary Purpose:
Diagnostic
Official Title:
Evaluating Pharmacogenomic Variants for Cardiology Therapeutics: the Lighthouse Pilot (Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects)
Actual Study Start Date :
Dec 3, 2020
Anticipated Primary Completion Date :
Jun 29, 2023
Anticipated Study Completion Date :
Jun 29, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Conventional Therapy (Controls)

Treatment with clopidogrel and no pre-emptive genotyping

Experimental: Genotype-guided therapy (experimental)

Treatment with clopidogrel 75 mg daily for non-carriers Treatment with ticagrelor 90 mg twice daily for carriers

Diagnostic Test: Cipherome Lighthouse Pilot
Preemptive pharmacogenomic testing

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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)

  2. 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 Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Doctors Hospital at Renaissance Edinburg Texas United States 78539
2 Doctors Hospital at Renaissance Edinburg Texas United States 78539

Sponsors and Collaborators

  • Cipherome, Inc.
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Cipherome, Inc.
ClinicalTrials.gov Identifier:
NCT04702113
Other Study ID Numbers:
  • C03-002 DHR001
First Posted:
Jan 8, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cipherome, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022