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

Recruiting now · Phase 4

Conditions studied: ACS - Acute Coronary Syndrome, CYP2C19 Polymorphism

In brief

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.

Key facts

Study ID

NCT06283888

Run by

Zunyi Medical College

People needed

1200

Starts

2024-04-01

Expected to finish

2028-12-01

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)

Full record on ClinicalTrials.gov

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