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

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ClinicalTrials.gov Identifier: NCT04580602
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Cipherome, Inc.

Brief Summary:
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.

Condition or disease
Stent Thrombosis Ischemic Stroke Myocardial Infarction Acute Coronary Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

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)



Primary Outcome Measures :
  1. 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 1 year 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.


Secondary Outcome Measures :
  1. 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 1 year 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.

  2. 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 1 year of clopidogrel 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.


Other Outcome Measures:
  1. To discover novel pharmacogenetic variants associated with P2Y12 metabolism. [ Time Frame: Within 1 year of clopidogrel 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.


Biospecimen Retention:   Samples With DNA
Laboratory blood draw


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580602


Contacts
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Contact: Amy Kim, MD 4082431460 amy.kim@cipherome.com
Contact: Jane Chiang, MD 4082431460 ext 1007 jane.chiang@cipherome.com

Locations
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Korea, Republic of
SNUBH Recruiting
Seongnam-si, Gyonggi-do, Korea, Republic of
Contact: Jungwon Suh, MD       65411@snubh.org   
Sponsors and Collaborators
Cipherome, Inc.
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jungwon Suh, MD SNUBH
Additional Information:
Publications:
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.

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Responsible Party: Cipherome, Inc.
ClinicalTrials.gov Identifier: NCT04580602    
Other Study ID Numbers: C03-001 BD002
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Thrombosis
Acute Coronary Syndrome
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis