Evaluating Pharmacogenomic Variants for Cardiology Therapeutics (CARES2)

Cipherome

Status: Completed

Conditions: Ischemic Stroke; Thrombosis; Myocardial Infarction; Bleeding; Stent Thrombosis

Treatments: Diagnostic Test: Cipherome Lighthouse Pilot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04702113

C03-002 DHR001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.
• Lost to follow-up prior to 60 days.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Conventional Therapy (Controls)

No Intervention group

Description:

Treatment with clopidogrel and no pre-emptive genotyping

Genotype-guided therapy (experimental)

Experimental group

Description:

1. Treatment with clopidogrel 75 mg daily for non-carriers 2. Treatment with ticagrelor 90 mg twice daily for carriers

Treatment:

Diagnostic Test: Cipherome Lighthouse Pilot