Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283888
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-21
Brief Title:
CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention
Sponsor:
Zunyi Medical College
Organization:
Zunyi Medical College
Study Overview
Official Title:
Safety and Efficacy of CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection Versus Conventional Antiplatelet Therapy After Complex Percutaneous Coronary Intervention The PRECISE-PCI Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
In Ease Asia clinical trials P2Y12 inhibitor ticagrelor or clopidogrel monotherapy after 3-month dual antiplatelet therapy DAPT resulted in a lower incidence of clinically significant bleeding without increasing risk of major adverse cardiac and cerebrovascular events even if acute coronary syndrome ACS following complex percutaneous coronary intervention PCI when compared with standard DAPT Although better understood East Asian Paradox finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice
Detailed Description:
In the PRECISE-PCI CYP2C19 Genotype-Guided P2Y12 RECeptor Inhibitor SElection After Complex PCI trial the investigators aim to evaluate the safety and efficacy of CYP2C19 genotype-guided P2Y12 receptor inhibitor selection as compared with conventional therapy in Chinese with ACS undergoing complex PCI All eligible ACS patients will be received DAPT ticagrelor 180 mg or clopidogrel 300600 mg plus aspirin 300 mg loading before PCI Subsequently to be randomly assigned into the genotype-guided group CPY2C19 2 or 3 carrier ticagrelor 60 mg bid or 45mg bid if 50 kg 75 years CPY2C19 2 or 3 non-carrier clopidogrel 75 mg qd in combination with aspirin 100 mg qd and conventional group ticagrelor 90 mg bid or clopidogrel 75 mg qd in combination with aspirin 100 mg qd At post-PCI 3 months both groups will be treated with mono-ticagrelorclopidogrel without aspirin therapy for a further 9 months
The primary endpoint is focusing on the net adverse clinical events NACEs a composite of cardiac death non-fatal myocardial infarction target vessellesion revascularization stroke or BARC-defined clinically significant bleeding type 2 3 or 5 during 12-month follow-ups
The primary endpoint is focusing on the net adverse clinical events NACEs a composite of cardiac death non-fatal myocardial infarction target vessellesion revascularization stroke or BARC-defined clinically significant bleeding type 2 3 or 5 during 12-month follow-ups
Study Oversight
Has Oversight DMC:
None
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?:
None