NCT06283888

CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Zunyi Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 300/600 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-ticagrelor/clopidogrel 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 vessel/lesion revascularization, stroke, or BARC-defined clinically significant bleeding type 2, 3, or 5) during 12-month follow-ups.

Conditions

• ACS - Acute Coronary Syndrome
• CYP2C19 Polymorphism

Interventions

Type	Name	Description
DRUG	CYP2C19 Genotype Guided DAPT	Patients with \*2 or \*3 carrier will be received ticagrelor 60mg or 45mg bid (if \<50 kg, ≥75 years) + aspirin 100 mg qd; Patients with \*2 or \*3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd
DRUG	Conventional DAPT	Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-04-01
• Completion: 2028-12-01
• First posted: 2024-02-28
• Last updated: 2024-03-20

Locations

1 site across 1 country: China