Cipherome Lighthouse Pilot for Stroke

Phase-Based Progress Estimates

Effectiveness

Safety

Stroke+9 MoreCipherome Lighthouse Pilot - DiagnosticTest

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial aims to test whether the use of Cipherome's Lighthouse can improve patient outcomes.

Eligible Conditions

Stroke
Heart Attack
Bleeding
Stent Thrombosis
Blood Clot

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

NCS-01

Medium ACT Target

Indication for H. pylori testing

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Study pilot duration is 365 days (1 year)

Year 1

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

Evaluation of aggregate costs

Reduction of major or minor bleeding events

Reduction of treatment failures

Trial Safety

Safety Progress

1 of 3

Similar Trials

NCS-01

Medium ACT Target

Indication for H. pylori testing

Trial Design

2 Treatment Groups

Conventional Therapy (Controls)

1 of 2

Genotype-guided therapy (experimental)

1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Cipherome Lighthouse Pilot · No Placebo Group · N/A

Genotype-guided therapy (experimental)

DiagnosticTest

Experimental Group · 1 Intervention: Cipherome Lighthouse Pilot · Intervention Types: DiagnosticTest

Conventional Therapy (Controls)NoIntervention Group · 1 Intervention: Conventional Therapy (Controls) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: study pilot duration is 365 days (1 year)

Who is running the clinical trial?

Cipherome, Inc.Lead Sponsor

6 Previous Clinical Trials

915 Total Patients Enrolled

DHR Health Institute for Research and DevelopmentOTHER

10 Previous Clinical Trials

3,336 Total Patients Enrolled

1 Trials studying Stroke

77 Patients Enrolled for Stroke

Yetunde O Kare Opaneye, MDStudy DirectorDHR Health

Herschl Silberman, MDPrincipal InvestigatorDHR Health

Humberto Mochizu Kitamayo, MDStudy DirectorDHR Health

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

References

Mehran, Roxana, Sunil V. Rao, Deepak L. Bhatt, C. Michael Gibson, Adriano Caixeta, John Eikelboom, Sanjay Kaul, et al.. 2011. “Standardized Bleeding Definitions for Cardiovascular Clinical Trials”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.110.009449.
Claudio-Campos, Karla, Jorge Duconge, Carmen L. Cadilla, and Gualberto Ruaño. 2015. “Pharmacogenetics of Drug-metabolizing Enzymes in US Hispanics”. Drug Metabolism and Personalized Therapy. Walter de Gruyter GmbH. doi:10.1515/dmdi-2014-0023.
Lee, Craig R., Vindhya B. Sriramoju, Alexandra Cervantes, Lucius A. Howell, Nicholas Varunok, Shivanshu Madan, Kasey Hamrick, et al.. 2018. “Clinical Outcomes and Sustainability of Using cyp2c19 Genotype–guided Antiplatelet Therapy After Percutaneous Coronary Intervention”. Circulation: Genomic and Precision Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circgen.117.002069.
Wasfy, Jason H., Jordan B. Strom, Stephen W. Waldo, Cashel O'Brien, Neil J. Wimmer, Adrian H. Zai, Jennifer Luttrell, et al.. 2014. “Clinical Preventability of 30‐day Readmission After Percutaneous Coronary Intervention”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.114.001290.
Levine, Glenn N., Eric R. Bates, John A. Bittl, Ralph G. Brindis, Stephan D. Fihn, Lee A. Fleisher, Christopher B. Granger, et al.. 2016. “2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2016.07.044.
Mega, Jessica L., Tabassome Simon, Jean-Philippe Collet, Jeffrey L. Anderson, Elliott M. Antman, Kevin Bliden, Christopher P. Cannon, et al.. 2010. “Reduced-function CYP2C19 Genotype and Risk of Adverse Clinical Outcomes Among Patients Treated with Clopidogrel Predominantly for PCI”. Jama. American Medical Association (AMA). doi:10.1001/jama.2010.1543.
Pereira, Naveen L., Michael E. Farkouh, Derek So, Ryan Lennon, Nancy Geller, Verghese Mathew, Malcolm Bell, et al.. 2020. “Effect of Genotype-guided Oral P2Y12 Inhibitor Selection Vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention”. Jama. American Medical Association (AMA). doi:10.1001/jama.2020.12443.
Limdi, Nita A., Larisa H. Cavallari, Craig R. Lee, William B. Hillegass, Ann M. Holmes, Todd C. Skaar, Maria Pisu, et al.. 2020. “Cost-effectiveness of Cyp2c19-guided Antiplatelet Therapy in Patients with Acute Coronary Syndrome and Percutaneous Coronary Intervention Informed by Real-world Data”. The Pharmacogenomics Journal. Springer Science and Business Media LLC. doi:10.1038/s41397-020-0162-5.
Parks, Anna, and Margaret Fang. 2017. “Scoring Systems for Estimating the Risk of Anticoagulant-associated Bleeding”. Seminars in Thrombosis and Hemostasis. Georg Thieme Verlag KG. doi:10.1055/s-0037-1598061.
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
Pereira, Naveen L., Michael E. Farkouh, Derek So, Ryan Lennon, Nancy Geller, Verghese Mathew, Malcolm Bell, et al.. 2020. “Effect of Genotype-guided Oral P2Y12 Inhibitor Selection Vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention”. Jama. American Medical Association (AMA). doi:10.1001/jama.2020.12443.
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.
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
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.
MEPS 2019. Agency for Healthcare Research and Quality. Medical Expenditure Panel Survey. MEPS HC-197A: 2017. Prescribed Medicines File. July 2019.
Mehran, Roxana, Sunil V. Rao, Deepak L. Bhatt, C. Michael Gibson, Adriano Caixeta, John Eikelboom, Sanjay Kaul, et al.. 2011. “Standardized Bleeding Definitions for Cardiovascular Clinical Trials”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.110.009449.
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
Johnson, Samuel G., Don Gruntowicz, Theresa Chua, and Robert J. Morlock. 2015. “Financial Analysis of CYP2C19 Genotyping in Patients Receiving Dual Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention”. Journal of Managed Care & Specialty Pharmacy. Academy of Managed Care Pharmacy. doi:10.18553/jmcp.2015.21.7.552.
Yost, Gregory W., Stefanie L. Puher, Jove Graham, Thomas D. Scott, Kimberly A. Skelding, Peter B. Berger, and James C. Blankenship. 2013. “Readmission in the 30 Days After Percutaneous Coronary Intervention”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2012.10.015.
Pereira NL, Rihal CS, So DYF, Rosenberg Y, Lennon RJ, Mathew V, Goodman SG, Weinshilboum RM, Wang L, Baudhuin LM, Lerman A, Hasan A, Iturriaga E, Fu YP, Geller N, Bailey K, Farkouh ME. Clopidogrel Pharmacogenetics. Circ Cardiovasc Interv. 2019 Apr;12(4):e007811. doi: 10.1161/CIRCINTERVENTIONS.119.007811. Review.
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.
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.
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.
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.
Pereira NL, Rihal CS, So DYF, Rosenberg Y, Lennon RJ, Mathew V, Goodman SG, Weinshilboum RM, Wang L, Baudhuin LM, Lerman A, Hasan A, Iturriaga E, Fu YP, Geller N, Bailey K, Farkouh ME. Clopidogrel Pharmacogenetics. Circ Cardiovasc Interv. 2019 Apr;12(4):e007811. doi: 10.1161/CIRCINTERVENTIONS.119.007811.
Dean L. Prasugrel Therapy and CYP Genotype. 2017 Apr 10. In: Pratt VM, Scott SA, Pirmohamed M, Esquivel B, Kattman BL, Malheiro AJ, editors. Medical Genetics Summaries [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK425796/
2020. "Evaluating Pharmacogenomic Variants for Cardiology Therapeutics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04702113.

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Cipherome Lighthouse Pilot for Stroke

Study Summary

Treatment Effectiveness

Effectiveness Progress

Similar Trials

Study Objectives

Trial Safety

Safety Progress

Similar Trials

Trial Design

2 Treatment Groups

Conventional Therapy (Controls)

1 of 2

Genotype-guided therapy (experimental)

1 of 2

Trial Logistics

Trial Timeline

Who is running the clinical trial?

Eligibility Criteria

Other Trials to Consider

NCS-01for Stroke

Medium ACT Targetfor Coronary Artery Disease

Indication For H. Pylori Testingfor Helicobacter Pylori Infection

Head Of Bed Positioningfor Stroke

MultiStemfor Stroke

Tricagrelorfor Bleeding Complications

BQ 2.0 Active Stimulation Groupfor Stroke

Diagnostic Coronary Angiography With Non-Obstructive CADfor Coronary Microvascular Disease

BCI-FES Dorsiflexion Therapyfor Stroke

Endovascular Thrombectomy (EVT)for Stroke

Thermogard XP3for Stroke

TargEted MAnageMent Intervention (TEAM)for Stroke

Ischemic Conditioningfor Stroke

ARM-programfor Stroke, Chronic

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