AzTrials
AzTrials

ThrombosisCARES2NCT04702113

Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

A study testing Cipherome Lighthouse Pilot in people with Thrombosis and Stent Thrombosis, run by Cipherome, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Thrombosis, Stent Thrombosis, Bleeding
What is being tested?
Cipherome Lighthouse Pilot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
3 Dec 2020to 27 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects over 18 years of age, who are:
  • On clopidogrel, prasugrel or ticagrelor after percutaneous stent
  • Completed informed consent

Who cannot join

  • Failure to provide informed consent.
  • Lost to follow-up prior to 60 days.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Doctors Hospital at Renaissance

    Edinburg, Texas, 78539

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Cipherome Lighthouse Pilot
Keywords
Stent Thrombosis, Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Medical subject headings
Thrombosis, Hemorrhage, Myocardial Infarction, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cipherome Lighthouse PilotDiagnostic test

    Preemptive pharmacogenomic testing

Study groups in NCT04702113
Study groupRoleWhat they receive
Conventional Therapy (Controls)No interventionTreatment with clopidogrel and no pre-emptive genotyping
Genotype-guided therapy (experimental)Experimental1. Treatment with clopidogrel 75 mg daily for non-carriers 2. Treatment with ticagrelor 90 mg twice daily for carriers
Receives: Diagnostic Test: Cipherome Lighthouse Pilot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of aggregate costs

    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.

    Measured: Study pilot duration is 365 days (1 year)

Secondary outcomes (2)

  1. Reduction of treatment failures

    Reduced treatment failures within 30, 60, 90 days, and 12 months of receiving clopidogrel in participants with reduced function alleles (CYP2C19 *2 or *3)

    Measured: Study pilot duration is 365 days (1 year)

  2. Reduction of major or minor bleeding events

    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)

    Measured: Study pilot duration is 365 days (1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021
  2. Study start3 Dec 2020
  3. Primary completion26 Jul 2023
  4. Study completion27 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04702113
Sponsor's protocol ID
C03-002 DHR001
Acronym
CARES2
Status last verified
Sep 2023
First submitted
14 Dec 2020
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Claudio-Campos K, Duconge J, Cadilla CL, Ruano G. Pharmacogenetics of drug-metabolizing enzymes in US Hispanics. Drug Metab Pers Ther. 2015 Jun;30(2):87-105. doi: 10.1515/dmdi-2014-0023.

    PubMed 25431893

  • Dean L, Kane M. Prasugrel Therapy and CYP Genotype. 2017 Apr 10 [updated 2024 Oct 15]. In: Pratt VM, Scott SA, Pirmohamed M, Esquivel B, Kattman BL, Malheiro AJ, editors. MINI Medical Genetics Summaries [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK425796/

    PubMed 28520385

  • Lee CR, Sriramoju VB, Cervantes A, Howell LA, Varunok N, Madan S, Hamrick K, Polasek MJ, Lee JA, Clarke M, Cicci JD, Weck KE, Stouffer GA. Clinical Outcomes and Sustainability of Using CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. Circ Genom Precis Med. 2018 Apr;11(4):e002069. doi: 10.1161/CIRCGEN.117.002069.

    PubMed 29615454

  • Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr, Halperin JL, Levine GN, Al-Khatib SM, Birtcher KK, Bozkurt B, Brindis RG, Cigarroa JE, Curtis LH, Fleisher LA, Gentile F, Gidding S, Hlatky MA, Ikonomidis JS, Joglar JA, Pressler SJ, Wijeysundera DN. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Thorac Cardiovasc Surg. 2016 Nov;152(5):1243-1275. doi: 10.1016/j.jtcvs.2016.07.044. No abstract available.

    PubMed 27751237

  • Limdi NA, Cavallari LH, Lee CR, Hillegass WB, Holmes AM, Skaar TC, Pisu M, Dillon C, Beitelshees AL, Empey PE, Duarte JD, Diaby V, Gong Y, Johnson JA, Graves J, Garbett S, Zhou Z, Peterson JF; Implementing GeNomics In pracTicE (IGNITE) Network Pharmacogenetic Working Group (IGNITE-PGx). Cost-effectiveness of CYP2C19-guided antiplatelet therapy in patients with acute coronary syndrome and percutaneous coronary intervention informed by real-world data. Pharmacogenomics J. 2020 Oct;20(5):724-735. doi: 10.1038/s41397-020-0162-5. Epub 2020 Feb 11.

    PubMed 32042096

  • Mega JL, Simon T, Collet JP, Anderson JL, Antman EM, Bliden K, Cannon CP, Danchin N, Giusti B, Gurbel P, Horne BD, Hulot JS, Kastrati A, Montalescot G, Neumann FJ, Shen L, Sibbing D, Steg PG, Trenk D, Wiviott SD, Sabatine MS. Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA. 2010 Oct 27;304(16):1821-30. doi: 10.1001/jama.2010.1543.

    PubMed 20978260

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PubMed 21670242

  • Parks AL, Fang MC. Scoring Systems for Estimating the Risk of Anticoagulant-Associated Bleeding. Semin Thromb Hemost. 2017 Jul;43(5):514-524. doi: 10.1055/s-0037-1598061. Epub 2017 Mar 30.

    PubMed 28359135

  • Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, Bell M, Bae JH, Jeong MH, Chavez I, Gordon P, Abbott JD, Cagin C, Baudhuin L, Fu YP, Goodman SG, Hasan A, Iturriaga E, Lerman A, Sidhu M, Tanguay JF, Wang L, Weinshilboum R, Welsh R, Rosenberg Y, Bailey K, Rihal C. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):761-771. doi: 10.1001/jama.2020.12443.

    PubMed 32840598

  • Wasfy JH, Strom JB, Waldo SW, O'Brien C, Wimmer NJ, Zai AH, Luttrell J, Spertus JA, Kennedy KF, Normand SL, Mauri L, Yeh RW. Clinical preventability of 30-day readmission after percutaneous coronary intervention. J Am Heart Assoc. 2014 Sep 26;3(5):e001290. doi: 10.1161/JAHA.114.001290.

    PubMed 25261531

  • 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 GW, Puher SL, Graham J, Scott TD, Skelding KA, Berger PB, Blankenship JC. Readmission in the 30 days after percutaneous coronary intervention. JACC Cardiovasc Interv. 2013 Mar;6(3):237-44. doi: 10.1016/j.jcin.2012.10.015.

    PubMed 23517834

Questions about this trial

What is this clinical trial studying?

A study testing Cipherome Lighthouse Pilot in people with Thrombosis and Stent Thrombosis, run by Cipherome, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of aggregate costs (time frame: Study pilot duration is 365 days (1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04702113, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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