Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05516784
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-08-23
Brief Title:
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile Among Coronary Artery Disease CAD Patients Undergoing Percutaneous Coronary Intervention PCI
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
Several studies have shown that pharmacodynamic PD response varies between patients treated with clopidogrel and that individuals with reduced response have an increased risk of recurrent ischemic events particularly in patients undergoing percutaneous coronary intervention This is due to several factors influencing the response to clopidogrel including genetic variations of the cytochrome P450 CYP 2C19 enzyme Loss of function LOF carriers of the CYP2C19 gene are associated with the decreased generation of the active metabolite clopidogrel and decreased platelet inhibition which translates to an increased rate of adverse cardiovascular events particularly in the setting of percutaneous coronary intervention PCI Thus drug regulatory authorities have cautioned about the decreased efficacy of clopidogrel among individuals with CYP2C19 LOF carriers and suggested using alternative therapies to inhibit p2Y12 Ticagrelor is a new generation P2Y12 receptor inhibitor with greater efficacy for PD and reduced rates of ischemic events compared with clopidogrel and are not affected by the CYP2C19 LOF polymorphism However in clinical practice the genotype-guided selection strategy for the oral P2Y12 inhibitor has been limited despite intensive research efforts This is due to the interaction of cardiovascular risk factors and molecular and biochemical complications that lead to poor response to platelet inhibitor therapy which impedes physicians ability to prescribe a more effective and personalized antiplatelet therapy Therefore we must move away from traditional approaches and use integrated systems biology study designs and disciplines to bridge the gap between genotype phenotype disease manifestation andor recurrence Pharmacometabolomics is a rapidly developing field that takes advantage of a systems pharmacology approach to probe the molecular pathways involved in drug response variability to understand metabolic changes and identify novel biomarkers that can be used to predict response more comprehensively Using profiles of changes in metabolites can help establish drug exposure fingerprints and clarify the determinants of drug response This study aims to investigate the Impact of pharmacogenetics-guided clopidogrel and ticagrelor treatment on platelet function test and its association with metabolomics in Coronary Artery Disease CAD patients undergoing PCI in Malaysia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None