Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects (CARES1)

February 15, 2023 updated by: Cipherome, Inc.

Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology

The goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on P2Y12 inhibitors.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this study it to validate Cipherome's drug safety score (DSS) in its predictive accuracy for severe adverse drug reactions (ADRs). The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an ADR and scores above 0.7 correlated with a lower chance of an ADR.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects (status post myocardial infarction and percutaneous coronary insertion) who have experienced adverse drug events while on P2Y12 inhibitors in order to improve future prediction and prevention of adverse events.

Description

Inclusion Criteria:

  1. Patients 18 years and older, who are on P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor).
  2. Ability to provide informed consent.

Exclusion Criteria:

1. Lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ADR Group
Major Bleeding BARC Bleeding Criteria Type 2,3,5
Control Group
No ADR or treatment failure, case-control matched to experimental groups
Treatment Failure Group
Major Adverse Cardiovascular Events (MACE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the predictive accuracy of Cipherome's drug safety score (DSS) in correlating with serious ADRs in subjects on P2Y12 inhibitors.
Time Frame: Within 24 months of clopidogrel therapy initiation
The primary endpoint is to assess the predictive accuracy of the DSS compared to actual clinical outcomes of treatment failure (major adverse cardiovascular events or MACE) or bleeding (per BARC criteria) in subjects on P2Y12 inhibitors. The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an ADR and scores above 0.7 correlated with a lower chance of an ADR.
Within 24 months of clopidogrel therapy initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the predictive accuracy of the DSS in correlating with serious ADRs compared to clinical guidelines (e.g., Clinical Pharmacogenetics Implementation Consortium (CPIC)) in subjects on P2Y12 inhibitors.
Time Frame: Within 24 months of clopidogrel therapy initiation
The secondary endpoint is to assess the predictive accuracy of the DSS compared to current evidence-based clinical guidelines, such as CPIC, for serious ADRs (e.g., treatment failure such as MACE) for subjects on P2Y12 inhibitors.
Within 24 months of clopidogrel therapy initiation
To assess the predictive accuracy of the DSS in correlating with major bleeding compared to clinical guidelines (CPIC) in subjects on P2Y12 inhibitors.
Time Frame: Within 24 months of clopidogrel therapy initiation
The secondary endpoint is to assess the predictive accuracy of the DSS compared to CPIC, for major bleeding per BARC criteria, in subjects on P2Y12 inhibitors.
Within 24 months of clopidogrel therapy initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To discover novel pharmacogenetic variants associated with P2Y12 metabolism.
Time Frame: Within 24 months of clopidogrel therapy initiation
We will assess the DSS within genes and evaluate the genetic-pathways for P2Y12 metabolism. Novel variants will be assessed using whole genome sequencing to evaluate the genetic pathways in individuals with serious ADRs and treatment failures. Through our analyses we intend to identify novel genetic variants in subjects with serious ADRs or treatment failure while on P2Y12 inhibitors.
Within 24 months of clopidogrel therapy initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cipherome, Inc.

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jungwon Suh, MD, SNUBH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

June 9, 2022

Study Completion (Actual)

June 9, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C03-001 BD002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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