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
|Condition or disease|
|Stent Thrombosis Ischemic Stroke Myocardial Infarction Acute Coronary Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
Major Bleeding BARC Bleeding Criteria Type 2,3,5
No ADR or treatment failure, case-control matched to experimental groups
Treatment Failure Group
Major Adverse Cardiovascular Events (MACE)
- 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.
- 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.
- 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.
- 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
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
|Contact: Amy Kim, MDfirstname.lastname@example.org|
|Contact: Jane Chiang, MD||4082431460 ext email@example.com|
|Korea, Republic of|
|Seongnam-si, Gyonggi-do, Korea, Republic of|
|Contact: Jungwon Suh, MD firstname.lastname@example.org|
|Principal Investigator:||Jungwon Suh, MD||SNUBH|