NCT04580602

Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Cipherome, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stent Thrombosis
• Ischemic Stroke
• Myocardial Infarction
• Acute Coronary Syndrome

Timeline

• Start date: 2020-10-07
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2020-10-08
• Last updated: 2023-02-16

Locations

1 site across 1 country: South Korea