Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04580602
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2020-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects
Sponsor:
Cipherome, Inc.
Organization:
Study Overview
Official Title:
Correlation Between Bleeding Complication and Treatment Failure on P2Y12 Inhibitors and Its Predictions Based on Cipherome's Pharmacogenomic Technology
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARES1
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: