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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Clinical Criteria:

‣ Patients aged between 18-80 years old.

⁃ Patients with ACS (UA/NSTEMI/STEMI) undergoing PCI.

⁃ Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months.

⁃ Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping.

⁃ Patients provide written informed consent before enrollment.

• Angiographic Criteria (meet at least 1 of the following characteristics):

‣ Thrombotic target lesion.

⁃ Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy

⁃ Multivessel (≥2 vessels) disease will be treated.

⁃ Multi-target lesions (≥3 lesions) will be treated.

⁃ Multi-stent (≥3 stents) will be implanted.

⁃ Total stent length≥60 mm.

⁃ Bifurcation lesion requiring at least 2 stents.

⁃ PCI for left main.

⁃ PCI for chronic total occlusion.

⁃ PCI for bypass graft.

Locations
Other Locations
China
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
Contact Information
Primary
Cai De Jin, MD
jincaide1118@163.com
86+173-8576-9997
Backup
Yan Yan Jin, MD
jinyanyan850925@163.com
86+157-7229-0925
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 1200
Treatments
Experimental: CYP2C19 Genotype Guided DAPT
Patients with CYP2C19 \*2 or \*3 carrier will be received ticagrelor 60mg or 45mg bid (if \<50 kg, ≥75 years) + aspirin 100 mg Patients with CYP2C19 \*2 or \*3 non-carrier will be received clopidogrel 75mg qd + aspirin 100 mg qd~At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months.
Experimental: Conventional DAPT
Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd~At post-PCI 3 months, monotherapy P2Y12 inhibitor (ticagrelor or clopidogrel) will be treated for a further 9 months.
Sponsors
Leads: Zunyi Medical College

This content was sourced from clinicaltrials.gov

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