Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06283888

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

Led by Zunyi Medical College · Updated on 2024-03-20

1200

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 80 years old
  • Patients diagnosed with acute coronary syndrome (unstable angina, NSTEMI, or STEMI) undergoing percutaneous coronary intervention
  • Patients treated with dual antiplatelet therapy including P2Y12 inhibitors and aspirin for at least 3 months
  • Patients willing to provide a blood sample for CYP2C19 genetic testing
  • Patients able to provide written informed consent
  • Patients with at least one of the following angiographic features: thrombotic target lesion; calcified lesion requiring rotational atherectomy or intravascular lithotripsy; multivessel disease (two or more vessels treated); multiple target lesions (three or more lesions treated); implantation of three or more stents; total stent length of 60 mm or more; bifurcation lesion requiring at least two stents; PCI for left main artery; PCI for chronic total occlusion; PCI for bypass graft
Not Eligible

You will not qualify if you...

  • Known CYP2C19 genotype prior to randomization
  • Expected to stop clopidogrel or ticagrelor treatment during 12-month follow-up
  • Planned surgery within 90 days
  • Need for oral anticoagulation therapy (e.g., atrial fibrillation, deep vein thrombosis, pulmonary embolism)
  • Intracranial, gastrointestinal, or urogenital bleeding within 6 months
  • Active bleeding, bleeding disorders, low platelet count (below 100,000/mL), or low hemoglobin (below 10 g/dL)
  • Liver dysfunction with liver enzymes more than three times normal
  • Kidney failure with estimated glomerular filtration rate below 15 ml/min/1.73m2 or dialysis requirement
  • Taking strong CYP3A4 inhibitors or inducers
  • Life expectancy less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563003

Actively Recruiting

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Research Team

C

Cai De Jin, MD

CONTACT

Y

Yan Yan Jin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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