Genotype-guided selection of P2Y12 inhibitors after complex heart procedures

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

This study is testing if choosing heart medication based on a person's genes can help people with acute coronary syndrome feel better after complex heart procedures while reducing side effects.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zunyi Medical College (other)
• Locations: 1 site (Zunyi, Guizhou)
• Trial ID: NCT06283888 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of selecting P2Y12 receptor inhibitors based on CYP2C19 genotype in patients with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI). Participants will first receive dual antiplatelet therapy (DAPT) before being randomly assigned to either a genotype-guided treatment group or a conventional therapy group. The primary focus is on the occurrence of net adverse clinical events over a 12-month follow-up period. The study aims to balance ischemic prevention with reduced bleeding risks by tailoring treatment based on genetic factors.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-80 with ACS who are undergoing complex PCI and are willing to provide a DNA sample for genotyping.

Not a fit: Patients with a known CYP2C19 genotype prior to randomization will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and safer treatment options for patients with ACS undergoing complex PCI.

How similar studies have performed: While there have been studies exploring genotype-guided therapies, this specific approach in the context of complex PCI is relatively novel.

Eligibility criteria

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

Where this trial is running

Zunyi, Guizhou

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

Study contacts

• Principal investigator: Cai De Jin — Zunyi Medical College
• Study coordinator: Cai De Jin, MD

Conditions: ACS - Acute Coronary Syndrome, CYP2C19 Polymorphism, CYP2C19 Genotype, P2Y12 Receptor Inhibitor, Complex PCI