Evaluating Pharmacogenomic Variants for Cardiology Therapeutics

Not Applicable

Completed

• Conditions: Bleeding; Ischemic Stroke; Myocardial Infarction; Thrombosis; Stent Thrombosis
• Interventions: Diagnostic Test: Cipherome Lighthouse Pilot

• Registration Number: NCT04702113
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype-guided therapy (experimental)	Cipherome Lighthouse Pilot	1. Treatment with clopidogrel 75 mg daily for non-carriers 2. Treatment with ticagrelor 90 mg twice daily for carriers

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Doctors Hospital at Renaissance; 🇺🇸 Edinburg, Texas, United States