Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Pharmacogenomic Variants for Cardiology Therapeutics (CARES2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702113
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Doctors Hospital at Renaissance
Information provided by (Responsible Party):
Cipherome, Inc.

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
Thrombosis Stent Thrombosis Bleeding Myocardial Infarction Ischemic Stroke Diagnostic Test: Cipherome Lighthouse Pilot Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
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 : December 3, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702113


Contacts
Layout table for location contacts
Contact: Jane Chiang, MD 4082431460 Jane.chiang@cipherome.com
Contact: Jose Estabil, ScM 4082431460 Jose.estabil@cipherome.com

Locations
Layout table for location information
United States, Texas
Doctors Hospital at Renaissance Recruiting
Edinburg, Texas, United States, 78539
Contact: Yetunde O Kare Opaneye, MD    956-362-8046    y.kareopaneye@dhr-rgv.com   
Principal Investigator: Herschl Silberman, MD         
Sub-Investigator: Humberto Mochizuki Tamayo, MD         
Doctors Hospital at Renaissance Recruiting
Edinburg, Texas, United States, 78539
Contact: Yetunde O Kare Opaneye, MD    956-362-8046    y.kareopaneye@dhr-rgv.com   
Principal Investigator: Herschl Silberman, MD         
Sub-Investigator: Humberto Mochizu Kitamayo, MD         
Sponsors and Collaborators
Cipherome, Inc.
Doctors Hospital at Renaissance
Investigators
Layout table for investigator information
Principal Investigator: Herschl Silberman, MD DHR Health
Study Director: Humberto Mochizu Kitamayo, MD DHR Health
Study Director: Yetunde O Kare Opaneye, MD DHR Health
Additional Information:
Publications:
Dean 2012. Dean L, Prasugrel Therapy and CYP Genotype. Medical Genetics Summaries, Pratt VM, McLeod HL, Rubinstein WS, et al., editors, Bethesda (MD): National Center for Biotechnology Information (US); 2012-. https://www.ncbi.nlm.nih.gov/books/NBK425796
MEPS 2019. Agency for Healthcare Research and Quality. Medical Expenditure Panel Survey. MEPS HC-197A: 2017. Prescribed Medicines File. July 2019.
Pereira 2019. Pereira NL, Charanjit S, Rihal MD et al. Clopidogrel Pharmacogenetics. State-of-the-Art Review and the TAILOR-PCI Study. Circ Cardiovasc Interv. 2019:1-11.
Pereira INTV 2020. CC News Story, TAILOR-PCI: Genotype-guided Antiplatelet Therapy Post PCI Misses Mark. American Academy of Cardiology. Pulled 18 September 2020. https://www.acc.org/latest-in-cardiology/articles/2020/03/24/16/41/sat-9am-tailor-pci-clinical-implementation-clopidogrel-pharmacogenetics-acc-2020.
Python 2020. Python code Mersenne Twister core generator with a period of (219937 -1). The Python Standard Library / Numeric and Mathematical Modules / random - Generate pseudo-random numbers. https://docs.python.org/3/library/random.html
Yost 2013. (Geisinger Health System) Yost D.W. et. al. "Readmission in the 30 Days After Percutaneous Coronary Intervention". JACC: Cardiovascular Interventions, Volume 6, Issue 3, March 2013, Pages 237-244. http://dx.doi.org/10.1016/j.jcin.2012.10.015

Layout table for additonal information
Responsible Party: Cipherome, Inc.
ClinicalTrials.gov Identifier: NCT04702113    
Other Study ID Numbers: C03-002 DHR001
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cipherome, Inc.:
Stent Thrombosis
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Thrombosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis