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

Launched by ZUNYI MEDICAL COLLEGE · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to select the best medication for patients with Acute Coronary Syndrome (ACS) after a procedure called Percutaneous Coronary Intervention (PCI), which helps open blocked arteries. The focus is on using a genetic test to guide the choice between two types of blood-thinning medications, ticagrelor and clopidogrel. The goal is to find a treatment that reduces the risk of bleeding while still preventing serious heart issues. Early results suggest that using just one of these medications after three months of combined therapy may be safer for certain patients.

To be eligible for this trial, participants should be between 18 and 80 years old, have been diagnosed with ACS, and need to undergo PCI. They must also agree to provide a blood sample for genetic testing and be willing to take the prescribed medications for at least a year. Participants can expect close monitoring during the study to ensure their safety and to gather important information about their health outcomes. This trial is currently recruiting participants and aims to improve treatment options for patients facing complex heart issues.

Gender

ALL

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