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Clinical Trials in China / NCT06283888
Recruiting Phase 4

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

NCT06283888 · tracked via the Priya Life Science China tracker
Sponsor
Zunyi Medical College
Phase
Phase 4
Started
2024-04-01
Last updated
2024-03-20

Condition(s) studied

ACS - Acute Coronary SyndromeCYP2C19 Polymorphism

Investigational drug(s) / intervention(s)

CYP2C19 Genotype Guided DAPTConventional DAPT →

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

Conventional DAPT: Patients will be conventionally received ticagrelor 90mg bid or clopidogrel 75mg qd + aspirin 100 mg qd

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: * Patient with known CYP2C19 genotype before randomization. * Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period. * Planned surgery within 90 days. * Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism) * Intracranial/gastrointestinal/urogenital bleeding within 6 months. * Active bleeding or bleeding diathesis, thrombocytopenia (platelet \<100,000/mL) or hemoglobin \<10 g/dL * Hepatic dysfunction (serum liver enzyme\>3 times the normal limit) * Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis) * Concomitant therapy with a strong CYP3A4 inhibitor or inducer * Life expectancy \< 1 year

Primary outcome measure(s)

  • NACE (net adverse clinical event) — At 12 months
    The incidence of NACE (composite of cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, stroke, or clinically significant bleeding according to BARC criteria).

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Recruiting

More Zunyi Medical College trials in China

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Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus Recruiting

Other trials for the same condition

Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283888 on ClinicalTrials.gov ↗ ← All trials in China