Genotype-guided selection of P2Y12 inhibitors after complex heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jincaide1118@163.com
• Phone: 86+173-8576-9997

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.